Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza (NCT NCT05052697)
NCT ID: NCT05052697
Last Updated: 2024-03-12
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1158 participants
Primary outcome timeframe
From Day 1 to Day 7 after Vaccination 1
Results posted on
2024-03-12
Participant Flow
This study was conducted across 2 substudies-Substudy A and Substudy B.
A total of 1158 participants (substudy A: 256+ substudy B: 902) were enrolled and randomized to receive study treatment.
Participant milestones
| Measure |
SSA: mIRV A (Dose Level 1) + QIV
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose level 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 2 administered 21 days apart as a part of initial enrollment.
|
SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received two doses of licensed QIV administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 1) as part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 2) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, dose combination 2 administered at day 1 as a part of initial enrollment.
|
SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of bIRV AA + bIRV BB both dose level combination 1 administered at day 1 as a part of initial enrollment.
|
SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as part of initial enrollment.
|
SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 3 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 2 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) at Day 1 as part of expanded enrollment.
|
SSB: 1 Dose of Licensed QIV, 1-visit Schedule: Expanded Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as a part of expanded enrollment.
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Expanded Enrollment
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of expanded enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy A
STARTED
|
15
|
15
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15
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15
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15
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15
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15
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16
|
15
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15
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15
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15
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15
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15
|
15
|
15
|
15
|
0
|
0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
|
|
Substudy A
Vaccination 1
|
15
|
15
|
15
|
14
|
15
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15
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15
|
16
|
14
|
15
|
15
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15
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15
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15
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15
|
15
|
15
|
0
|
0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
Vaccination 2
|
6
|
10
|
9
|
12
|
1
|
6
|
7
|
6
|
2
|
1
|
6
|
11
|
6
|
9
|
6
|
7
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
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|
Substudy A
COMPLETED
|
15
|
15
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15
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14
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15
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14
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15
|
16
|
14
|
15
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15
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15
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15
|
14
|
15
|
13
|
15
|
0
|
0
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0
|
0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
15
|
16
|
16
|
16
|
15
|
16
|
16
|
15
|
15
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
Vaccination 1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
15
|
16
|
16
|
16
|
15
|
16
|
16
|
14
|
15
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
Vaccination 2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
13
|
15
|
16
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
14
|
14
|
16
|
15
|
13
|
16
|
16
|
14
|
15
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
2
|
0
|
1
|
2
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy B: Expanded Enrollment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
132
|
133
|
117
|
117
|
115
|
117
|
|
Substudy B: Expanded Enrollment
Vaccination 1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
131
|
131
|
116
|
117
|
115
|
117
|
|
Substudy B: Expanded Enrollment
Vaccination 2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
101
|
|
Substudy B: Expanded Enrollment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
128
|
130
|
110
|
111
|
109
|
117
|
|
Substudy B: Expanded Enrollment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
3
|
7
|
6
|
6
|
0
|
Reasons for withdrawal
| Measure |
SSA: mIRV A (Dose Level 1) + QIV
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose level 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 2 administered 21 days apart as a part of initial enrollment.
|
SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received two doses of licensed QIV administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 1) as part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 2) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, dose combination 2 administered at day 1 as a part of initial enrollment.
|
SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of bIRV AA + bIRV BB both dose level combination 1 administered at day 1 as a part of initial enrollment.
|
SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as part of initial enrollment.
|
SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 3 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 2 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) at Day 1 as part of expanded enrollment.
|
SSB: 1 Dose of Licensed QIV, 1-visit Schedule: Expanded Enrollment
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as a part of expanded enrollment.
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Expanded Enrollment
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of expanded enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Substudy A
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
No longer met eligibility criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy A
Not vaccinated
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
SubStudy B: Initial Enrollment
Not vaccinated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Substudy B: Expanded Enrollment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
3
|
3
|
3
|
0
|
|
Substudy B: Expanded Enrollment
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
3
|
3
|
2
|
0
|
|
Substudy B: Expanded Enrollment
Refused study procedure
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Substudy B: Expanded Enrollment
Not vaccinated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
Baseline characteristics by cohort
| Measure |
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment
n=14 Participants
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose level 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment
n=15 Participants
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment
n=16 Participants
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 2 administered 21 days apart as a part of initial enrollment.
|
SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment
n=16 Participants
Participants aged 65 to 85 years received two doses of licensed QIV administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
n=16 Participants
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 1) as part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment
n=15 Participants
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 2) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment
n=16 Participants
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment
n=16 Participants
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, dose combination 2 administered at day 1 as a part of initial enrollment.
|
SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
n=14 Participants
Participants aged 65 to 85 years received a single intramuscular injection of bIRV AA + bIRV BB both dose level combination 1 administered at day 1 as a part of initial enrollment.
|
SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment
n=15 Participants
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as part of initial enrollment.
|
SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment
n=15 Participants
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 3 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment
n=131 Participants
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment
n=131 Participants
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 2 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
n=116 Participants
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
n=117 Participants
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) at Day 1 as part of expanded enrollment.
|
SSB: 1 Dose of Licensed QIV, 1-visit Schedule: Expanded Enrollment
n=115 Participants
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as a part of expanded enrollment.
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Expanded Enrollment
n=117 Participants
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of expanded enrollment.
|
Total
n=1149 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=116 Participants
|
|
Age, Customized
>=18 years
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
16 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
15 Participants
n=135 Participants
|
15 Participants
n=136 Participants
|
14 Participants
n=44 Participants
|
15 Participants
n=667 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=6 Participants
|
16 Participants
n=10 Participants
|
15 Participants
n=14 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=26 Participants
|
15 Participants
n=12 Participants
|
131 Participants
n=206 Participants
|
131 Participants
n=12 Participants
|
116 Participants
n=12 Participants
|
117 Participants
n=12 Participants
|
115 Participants
n=384 Participants
|
117 Participants
n=23 Participants
|
1149 Participants
n=116 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
10 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
9 Participants
n=10 Participants
|
8 Participants
n=14 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=26 Participants
|
9 Participants
n=12 Participants
|
77 Participants
n=206 Participants
|
74 Participants
n=12 Participants
|
61 Participants
n=12 Participants
|
60 Participants
n=12 Participants
|
67 Participants
n=384 Participants
|
65 Participants
n=23 Participants
|
629 Participants
n=116 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
9 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=6 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=14 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=26 Participants
|
6 Participants
n=12 Participants
|
54 Participants
n=206 Participants
|
57 Participants
n=12 Participants
|
55 Participants
n=12 Participants
|
57 Participants
n=12 Participants
|
48 Participants
n=384 Participants
|
52 Participants
n=23 Participants
|
520 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
4 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
12 Participants
n=44 Participants
|
9 Participants
n=667 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=6 Participants
|
8 Participants
n=10 Participants
|
8 Participants
n=14 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=26 Participants
|
14 Participants
n=12 Participants
|
74 Participants
n=206 Participants
|
77 Participants
n=12 Participants
|
50 Participants
n=12 Participants
|
60 Participants
n=12 Participants
|
55 Participants
n=384 Participants
|
55 Participants
n=23 Participants
|
546 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
11 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
11 Participants
n=135 Participants
|
10 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=14 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=26 Participants
|
1 Participants
n=12 Participants
|
57 Participants
n=206 Participants
|
54 Participants
n=12 Participants
|
65 Participants
n=12 Participants
|
56 Participants
n=12 Participants
|
60 Participants
n=384 Participants
|
62 Participants
n=23 Participants
|
598 Participants
n=116 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 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
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=23 Participants
|
5 Participants
n=116 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=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
|
2 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=7 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
6 Participants
n=206 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=384 Participants
|
1 Participants
n=23 Participants
|
20 Participants
n=116 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=384 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=26 Participants
|
1 Participants
n=12 Participants
|
20 Participants
n=206 Participants
|
20 Participants
n=12 Participants
|
21 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
14 Participants
n=384 Participants
|
11 Participants
n=23 Participants
|
143 Participants
n=116 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
13 Participants
n=115 Participants
|
12 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
15 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
13 Participants
n=135 Participants
|
13 Participants
n=136 Participants
|
13 Participants
n=44 Participants
|
10 Participants
n=667 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=6 Participants
|
12 Participants
n=10 Participants
|
13 Participants
n=14 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=26 Participants
|
14 Participants
n=12 Participants
|
98 Participants
n=206 Participants
|
107 Participants
n=12 Participants
|
92 Participants
n=12 Participants
|
101 Participants
n=12 Participants
|
96 Participants
n=384 Participants
|
104 Participants
n=23 Participants
|
964 Participants
n=116 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=384 Participants
|
0 Participants
n=23 Participants
|
8 Participants
n=116 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 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=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=384 Participants
|
1 Participants
n=23 Participants
|
8 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after Vaccination 1Population: Vaccination 1 safety population included all the participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Redness: Mild
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Redness: Moderate
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Swelling: Mild
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Swelling: Moderate
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Pain at injection site: Mild
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
50.0 Percentage of participants
Interval 23.0 to 77.0
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
29.4 Percentage of participants
Interval 10.3 to 56.0
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Pain at injection site: Moderate
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Pain at injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
Pain at injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after Vaccination 2Population: Vaccination 2 safety population included all the participants who received vaccination 2. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. Data for mIRV A + Licensed QIV is missing as there was no e-diary data transmitted.
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=8 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=3 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=7 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=23 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=6 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Redness: Moderate
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Swelling: Moderate
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Swelling: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Redness: Mild
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Redness: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Redness: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Swelling: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 14.8
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Swelling: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Pain at injection site: Mild
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 15.7 to 84.3
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
57.1 Percentage of participants
Interval 18.4 to 90.1
|
30.4 Percentage of participants
Interval 13.2 to 52.9
|
50.0 Percentage of participants
Interval 11.8 to 88.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Pain at injection site: Moderate
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
—
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Pain at injection site: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
Pain at injection site: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 After Vaccination 1Population: Vaccination 1 safety population included all participants who received the study vaccination 1. 'Number Analyzed' signifies number of participants evaluable for the specified rows. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Systemic events included fever, vomiting, diarrhea, headache,fatigue,chills,new/worsened muscle pain \& new/worsened joint pain \& recorded by participants in an electronic diary.Fever defined as oral temperature greater than equal to(\>=)38.0 degrees Celsius(deg C) \& categorized as\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as:Grade(G)1:1-2 times in 24 hours(h);G2:\>2 times in 24h;G3:required Intravenous (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 \& 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 or medically qualified person.Exact 2-sided confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fever: >38.9 deg C to 40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fever: >40.0 deg C
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fatigue: Moderate
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fatigue: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Headache: Moderate
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Chills: Mild
|
0 Percentage of participants
Interval 0.0 to 20.6
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Chills: Moderate
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Vomiting: Mild
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Diarrhea: Mild
|
0 Percentage of participants
Interval 0.0 to 20.6
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Diarrhea: Moderate
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened muscle pain: Mild
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened muscle pain: Moderate
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened joint pain: Moderate
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fatigue: Mild
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
11.8 Percentage of participants
Interval 1.5 to 36.4
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fever: >=38.0 deg C to 38.4 deg C
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fever: >38.4 deg C to 38.9 deg C
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Fatigue: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Headache: Mild
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
5.9 Percentage of participants
Interval 0.1 to 28.7
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
Headache: Severe
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened joint pain: Mild
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 19.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after Vaccination 2Population: Vaccination 2 safety population included all participants who received vaccination 2. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. Data for mIRV A + Licensed QIV is missing as there was no e-diary data transmitted.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: Grade(G) 1: 1-2 times in 24 h; G2: \>2 times in 24 h; G3: required IV hydration. Diarrhea graded as: G1: 2-3 loose stools in 24 h; G2: 4-5 loose stools in 24 h; G3: 6 or more loose stools in 24 h. Headache, fatigue, chills, new/worsened muscle pain \& 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 or medically qualified person. Exact 2-sided confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=8 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=3 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=7 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=23 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=6 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fever: >=38.0 deg C to 38.4 deg C
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fever: >38.4 deg C to 38.9 deg C
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fever: >38.9 deg C to 40.0 deg C
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fever: >40.0 deg C
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fatigue: Mild
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fatigue: Moderate
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of participants
Interval 3.2 to 65.1
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
—
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Headache: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened joint pain: Mild
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0.0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened joint pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened joint pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened joint pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fatigue: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Fatigue: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Headache: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Headache: Moderate
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Headache: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Chills: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Chills: Moderate
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Chills: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Chills: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Vomiting: Mild
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Vomiting: Moderate
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Vomiting: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Vomiting: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Diarrhea: Mild
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
14.3 Percentage of participants
Interval 0.4 to 57.9
|
0 Percentage of participants
Interval 0.0 to 14.8
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Diarrhea: Moderate
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Diarrhea: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
Diarrhea: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened muscle pain: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened muscle pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened muscle pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
New or worsened muscle pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
0 Percentage of participants
Interval 0.0 to 41.0
|
0 Percentage of participants
Interval 0.0 to 14.8
|
0 Percentage of participants
Interval 0.0 to 45.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to 4 weeks After Vaccination 1Population: Vaccination 1 safety population included all participants who received Vaccination 1.
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. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
50.0 Percentage of participants
Interval 23.0 to 77.0
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
17.6 Percentage of participants
Interval 3.8 to 43.4
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
PRIMARY outcome
Timeframe: From Day 1 up to 4 weeks After vaccination 2Population: Vaccination 2 safety population included all participants who received Vaccination 2.
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. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=11 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=3 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=37 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=21 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=32 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=7 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A
|
—
|
—
|
—
|
—
|
—
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
0 Percentage of participants
Interval 0.0 to 70.8
|
8.1 Percentage of participants
Interval 1.7 to 21.9
|
14.3 Percentage of participants
Interval 3.0 to 36.3
|
25.0 Percentage of participants
Interval 11.5 to 43.4
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From vaccination 1 on day 1 up to 6 months after vaccination 2Population: Safety population included all the participants who received the study intervention.
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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
7.1 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
5.9 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
6.7 Percentage of participants
|
PRIMARY outcome
Timeframe: 2 days after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall 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. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row.
Hematology parameters included erythrocytes, lymphocytes, neutrophils, eosinophils/leukocytes, erythrocyte (ery) mean corpuscular volume, ery. mean corpuscular hemoglobin and ery. mean corpuscular hemoglobin concentration. The primary criteria were as follows erythrocytes, lymphocytes, neutrophils: \<0.8\*lower limit of normal (LLN); Lymphocytes/Leukocytes, Eosinophils/Leukocytes, Monocytes/Leukocytes: \>1.2\*upper limit of normal (ULN); Ery. Mean Corpuscular Volume:\>1.1\*ULN; Ery. Mean Corpuscular Hemoglobin and Ery.Mean Corpuscular hemoglobin Concentration: \< 0.9\*LLN. Also add 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Erythrocytes
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Lymphocytes
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Neutrophils
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Eosinophils/Leukocytes
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Ery. Mean Corpuscular Volume
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Ery. Mean Corpuscular Hemoglobin
|
—
|
—
|
—
|
—
|
—
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Ery. Mean Corpuscular HGB Concentration
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
Monocytes/Leukocytes
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
0 Percentage of participants
Interval 0.0 to 21.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
PRIMARY outcome
Timeframe: 1 week after vaccination 1Population: Vaccination 1 safety population included all participants who received the study vaccination 1. Here, 'Overall 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.
Hematology parameters included erythrocytes, neutrophils, eosinophils/leukocytes, monocytes/leukocytes, ery mean corpuscular hemoglobin. The primary criteria were as follows erythrocytes and neutrophils: \<0.8\* LLN; Eosinophils/Leukocytes and Monocytes/Leukocytes: \>1.2\* ULN; Ery. Mean Corpuscular Hemoglobin:\>1.1\*ULN. 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=14 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=14 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
Erythrocytes
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
|
Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
Neutrophils
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
Eosinophils/Leukocytes
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
|
Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
Monocytes/Leukocytes
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 24.7
|
|
Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
Ery. Mean Corpuscular Hemoglobin
|
—
|
—
|
—
|
—
|
—
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 24.7
|
PRIMARY outcome
Timeframe: 2 days after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=14 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=13 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A
Blood Urea Nitrogen
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 23.2
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
|
Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A
C Reactive Protein
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
PRIMARY outcome
Timeframe: 1 week after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Chemistry parameters included blood urea nitrogen and C-reactive protein. The primary criteria were as follows Blood Urea Nitrogen: \> 1.3\*ULN; C Reactive Protein: \> 1.1\*ULN. Also add 95% CI was based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A
Blood Urea Nitrogen
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 20.6
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
|
Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A
C-reactive protein
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 23.2
|
0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0 Percentage of participants
Interval 0.0 to 21.8
|
0 Percentage of participants
Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: From Baseline (prior to vaccination 1) to 2 days after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, platelets decrease, white blood cells (WBC) decrease and WBC increase. Laboratory abnormalities were graded by Food and Drug Administration (FDA) toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=14 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=13 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Hemoglobin: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
7.7 Percentage of participants
|
14.3 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Neutrophil Decrease: Baseline Normal to Grade 1
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Hemoglobin: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Hemoglobin: Baseline Grade 1 to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Lymphocytes: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
15.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Lymphocytes: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
Platelets Decrease: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
WBC decrease: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
6.7 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
WBC increase: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline (prior to vaccination 1) to 1 week after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall 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.
Hematology parameters included hemoglobin, lymphocytes, neutrophils decrease, WBC decrease and WBC increase. Laboratory abnormalities were graded by FDA toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Hemoglobin: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Neutrophil decrease: Baseline Grade 2 to Grade 3
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
WBC decrease: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
WBC decrease: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
WBC increase: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
WBC increase: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Neutrophil decrease: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Neutrophil decrease: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Hemoglobin: Baseline Normal to Grade 1
|
6.3 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.7 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
6.3 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Lymphocytes: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
7.7 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
Lymphocytes: Baseline Grade 1 to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline (prior to vaccination 1) to 2 days after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 2 days after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased (ALP), Alkaline Phosphatase Increased (ALP), Aspartate Aminotransferase Increased (AST), Creatinine Increased and Urea Nitrogen.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=14 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=13 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
ALT Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
ALP Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.67 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
AST Increased: Baseline Normal to Grade 1
|
6.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
Creatinine Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
Urea Nitrogen: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.3 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
7.1 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
13.3 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
Urea Nitrogen: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
Urea Nitrogen: Baseline Grade 1 to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
6.3 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline (prior to vaccination 1) to 1 week after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Chemistry abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in chemistry values were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 week after vaccination 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported. The parameters reported were - Alanine Aminotransferase Increased, Alkaline Phosphatase Increased, Aspartate Aminotransferase Increased, Creatinine Increased and Urea Nitrogen.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
ALT Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
ALP Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.3 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
AST Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
13.3 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
Creatinine Increased: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
Urea Nitrogen: Baseline Normal to Grade 1
|
0 Percentage of participants
|
0 Percentage of participants
|
6.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6.3 Percentage of participants
|
14.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
Urea Nitrogen: Baseline Normal to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
Urea Nitrogen: Baseline Grade 1 to Grade 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: 2 days after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 1 week after vaccination 1Population: Vaccination 1 safety population included all participants who received vaccination 1.
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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccinationPopulation: Safety population included all the participants who received the study intervention.
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Redness: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Redness: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Swelling: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Swelling: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Swelling: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Redness: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Redness: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Swelling: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Mild
|
—
|
—
|
—
|
—
|
—
|
31.3 Percentage of participants
Interval 11.0 to 58.7
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
31.3 Percentage of participants
Interval 11.0 to 58.7
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Moderate
|
—
|
—
|
—
|
—
|
—
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 1Population: Safety population included all the participants who received the study intervention.
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Severe
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Mild
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Mild
|
—
|
—
|
—
|
—
|
—
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
31.3 Percentage of participants
Interval 11.0 to 58.7
|
25.0 Percentage of participants
Interval 7.3 to 52.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Moderate
|
—
|
—
|
—
|
—
|
—
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 2Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=13 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Redness: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Swelling: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Mild
|
—
|
—
|
—
|
—
|
—
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
Pain at injection site: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule armPopulation: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed'(n) = number of participants evaluable for specified rows.
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. Exact 2-sided confidence interval was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=114 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Swelling: Moderate
|
—
|
—
|
—
|
—
|
—
|
5.3 Percentage of participants
Interval 2.2 to 10.7
|
6.9 Percentage of participants
Interval 3.2 to 12.6
|
4.3 Percentage of participants
Interval 1.4 to 9.9
|
6.8 Percentage of participants
Interval 3.0 to 13.0
|
4.4 Percentage of participants
Interval 1.4 to 9.9
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Redness: Mild
|
—
|
—
|
—
|
—
|
—
|
6.1 Percentage of participants
Interval 2.7 to 11.7
|
10.7 Percentage of participants
Interval 6.0 to 17.3
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
4.3 Percentage of participants
Interval 1.4 to 9.7
|
2.6 Percentage of participants
Interval 0.5 to 7.5
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Redness: Moderate
|
—
|
—
|
—
|
—
|
—
|
3.8 Percentage of participants
Interval 1.3 to 8.7
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
3.4 Percentage of participants
Interval 0.9 to 8.5
|
1.8 Percentage of participants
Interval 0.2 to 6.2
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Redness: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Redness: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Swelling: Mild
|
—
|
—
|
—
|
—
|
—
|
4.6 Percentage of participants
Interval 1.7 to 9.7
|
9.9 Percentage of participants
Interval 5.4 to 16.4
|
5.2 Percentage of participants
Interval 1.9 to 11.0
|
3.4 Percentage of participants
Interval 0.9 to 8.5
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
8.7 Percentage of participants
Interval 4.2 to 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Swelling: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Swelling: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Pain at injection site: Mild
|
—
|
—
|
—
|
—
|
—
|
38.2 Percentage of participants
Interval 29.8 to 47.1
|
33.6 Percentage of participants
Interval 25.6 to 42.4
|
38.3 Percentage of participants
Interval 29.4 to 47.8
|
40.2 Percentage of participants
Interval 31.2 to 49.6
|
26.3 Percentage of participants
Interval 18.5 to 35.4
|
41.7 Percentage of participants
Interval 32.6 to 51.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Pain at injection site: Moderate
|
—
|
—
|
—
|
—
|
—
|
21.4 Percentage of participants
Interval 14.7 to 29.4
|
29.0 Percentage of participants
Interval 21.4 to 37.6
|
6.1 Percentage of participants
Interval 2.5 to 12.1
|
13.7 Percentage of participants
Interval 8.0 to 21.3
|
1.8 Percentage of participants
Interval 0.2 to 6.2
|
8.7 Percentage of participants
Interval 4.2 to 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Pain at injection site: Severe
|
—
|
—
|
—
|
—
|
—
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Pain at injection site: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Redness: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.1 Percentage of participants
Interval 1.1 to 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Redness: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.1 Percentage of participants
Interval 1.7 to 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Redness: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Redness: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Swelling: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.1 Percentage of participants
Interval 1.7 to 11.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Swelling: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.1 Percentage of participants
Interval 0.6 to 8.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Swelling: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Swelling: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Pain at injection site: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
33.7 Percentage of participants
Interval 24.4 to 43.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Pain at injection site: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.2 Percentage of participants
Interval 3.6 to 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Pain at injection site: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Pain at injection site: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccinationPopulation: Safety population included all the participants who received the study intervention.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Headache: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Chills: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Chills: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fever: >=38.0 degree C to 38.4 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fever: >38.4 degree C to 38.9 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fever: >38.9 degree C to 40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fever: >40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Moderate
|
—
|
—
|
—
|
—
|
—
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Fatigue: grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Headache: Mild
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Headache: Moderate
|
—
|
—
|
—
|
—
|
—
|
18.8 Percentage of participants
Interval 4.0 to 45.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Headache: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Chills: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
Chills: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Mild
|
—
|
—
|
—
|
—
|
—
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 1Population: Safety population included all the participants who received the study intervention.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Headache: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Chills: Mild
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Chills: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fever: >=38.0 degree C to 38.4°C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fever: >38.4 degree C to 38.9 degree C
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fever: >38.9 degree C to 40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fever: >40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Mild
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
31.3 Percentage of participants
Interval 11.0 to 58.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Moderate
|
—
|
—
|
—
|
—
|
—
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Fatigue: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Headache: Mild
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Headache: Moderate
|
—
|
—
|
—
|
—
|
—
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Headache: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Chills: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Chills: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Vomiting: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Mild
|
—
|
—
|
—
|
—
|
—
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
Diarrhea: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened muscle pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Mild
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
New or worsened joint pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From day 1 to day 7 of vaccination 2Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G: 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=13 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fever: >38.9 degree C to 40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fatigue: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Vomiting: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Diarrhea: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened muscle pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fever: >=38.0 degree C to 38.4 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fever: >38.4 degree C to 38.9 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fever: >40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fatigue: Mild
|
—
|
—
|
—
|
—
|
—
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fatigue: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Fatigue: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Headache: Mild
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Headache: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Headache: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Headache: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Chills: Mild
|
—
|
—
|
—
|
—
|
—
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Chills: Moderate
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Chills: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Chills: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Vomiting: Mild
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Vomiting: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Vomiting: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Diarrhea: Mild
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Diarrhea: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
Diarrhea: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened muscle pain: Mild
|
—
|
—
|
—
|
—
|
—
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened muscle pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened muscle pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened joint pain: Mild
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened joint pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened joint pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
New or worsened joint pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule armPopulation: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed'(n) = number of participants evaluable for specified rows.
Systemic events included fever, vomiting, diarrhea, headache, fatigue, chills, new/worsened muscle pain \& new /worsened joint pain \& recorded by participants in electronic diary. Fever defined as oral temperature \>=38.0 deg C \& categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C, \>38.9 to 40.0 deg C \& \>40.0 deg C. Vomiting graded as: G 1: 1-2 times in 24 hrs; G 2: \>2 times in 24 hrs; G 3: required IV hydration; G 4: emergency room visit/ hospitalization for hypotensive shock. Diarrhea graded as: G 1: 2-3 loose stools in 24 hrs; G 2: 4-5 loose stools in 24 hrs; G 3: 6 or more loose stools in 24 hrs \& G 4: emergency room visit/ hospitalization. Headache, fatigue, chills, new/worsened muscle pain \& new/worsened joint pain: G 1: didn't interfere with activity; G 2: some interference with activity; G 3: prevented daily routine activity \& G 4: emergency room visit/ hospitalization. Exact 2-sided confidence interval based on Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=114 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened muscle pain: Mild
|
—
|
—
|
—
|
—
|
—
|
13.0 Percentage of participants
Interval 7.7 to 20.0
|
13.0 Percentage of participants
Interval 7.7 to 20.0
|
8.7 Percentage of participants
Interval 4.2 to 15.4
|
10.3 Percentage of participants
Interval 5.4 to 17.2
|
4.4 Percentage of participants
Interval 1.4 to 9.9
|
9.6 Percentage of participants
Interval 4.9 to 16.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened muscle pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
13.7 Percentage of participants
Interval 8.4 to 20.8
|
18.3 Percentage of participants
Interval 12.1 to 26.0
|
7.8 Percentage of participants
Interval 3.6 to 14.3
|
11.1 Percentage of participants
Interval 6.1 to 18.3
|
2.6 Percentage of participants
Interval 0.5 to 7.5
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened muscle pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fever: >=38.0 degree C to 38.4 degree C
|
—
|
—
|
—
|
—
|
—
|
3.1 Percentage of participants
Interval 0.8 to 7.6
|
5.3 Percentage of participants
Interval 2.2 to 10.7
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
3.4 Percentage of participants
Interval 0.9 to 8.5
|
2.6 Percentage of participants
Interval 0.5 to 7.5
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fever: >38.4 degree C to 38.9 degree C
|
—
|
—
|
—
|
—
|
—
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fever: >38.9 degree C to 40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fever: >40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 31.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fatigue: Mild
|
—
|
—
|
—
|
—
|
—
|
15.3 Percentage of participants
Interval 9.6 to 22.6
|
16.8 Percentage of participants
Interval 10.8 to 24.3
|
13.9 Percentage of participants
Interval 8.2 to 21.6
|
21.4 Percentage of participants
Interval 14.3 to 29.9
|
12.3 Percentage of participants
Interval 6.9 to 19.7
|
9.6 Percentage of participants
Interval 4.9 to 16.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fatigue: Moderate
|
—
|
—
|
—
|
—
|
—
|
26.7 Percentage of participants
Interval 19.4 to 35.2
|
22.1 Percentage of participants
Interval 15.4 to 30.2
|
19.1 Percentage of participants
Interval 12.4 to 27.5
|
19.7 Percentage of participants
Interval 12.9 to 28.0
|
7.9 Percentage of participants
Interval 3.7 to 14.5
|
8.7 Percentage of participants
Interval 4.2 to 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fatigue: Severe
|
—
|
—
|
—
|
—
|
—
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
2.3 Percentage of participants
Interval 0.5 to 6.5
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Fatigue: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Headache: Mild
|
—
|
—
|
—
|
—
|
—
|
13.0 Percentage of participants
Interval 7.7 to 20.0
|
17.6 Percentage of participants
Interval 11.5 to 25.2
|
15.7 Percentage of participants
Interval 9.5 to 23.6
|
13.7 Percentage of participants
Interval 8.0 to 21.3
|
8.8 Percentage of participants
Interval 4.3 to 15.5
|
8.7 Percentage of participants
Interval 4.2 to 15.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Headache: Moderate
|
—
|
—
|
—
|
—
|
—
|
25.2 Percentage of participants
Interval 18.0 to 33.5
|
18.3 Percentage of participants
Interval 12.1 to 26.0
|
4.3 Percentage of participants
Interval 1.4 to 9.9
|
13.7 Percentage of participants
Interval 8.0 to 21.3
|
1.8 Percentage of participants
Interval 0.2 to 6.2
|
4.3 Percentage of participants
Interval 1.4 to 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Headache: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Headache: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Chills: Mild
|
—
|
—
|
—
|
—
|
—
|
9.9 Percentage of participants
Interval 5.4 to 16.4
|
9.9 Percentage of participants
Interval 5.4 to 16.4
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
9.4 Percentage of participants
Interval 4.8 to 16.2
|
4.4 Percentage of participants
Interval 1.4 to 9.9
|
7.8 Percentage of participants
Interval 3.6 to 14.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Chills: Moderate
|
—
|
—
|
—
|
—
|
—
|
9.2 Percentage of participants
Interval 4.8 to 15.5
|
9.9 Percentage of participants
Interval 5.4 to 16.4
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
7.7 Percentage of participants
Interval 3.6 to 14.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
4.3 Percentage of participants
Interval 1.4 to 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Chills: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Chills: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Vomiting: Mild
|
—
|
—
|
—
|
—
|
—
|
2.3 Percentage of participants
Interval 0.5 to 6.5
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.0
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Vomiting: Moderate
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Vomiting: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Vomiting: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Diarrhea: Mild
|
—
|
—
|
—
|
—
|
—
|
10.7 Percentage of participants
Interval 6.0 to 17.3
|
5.3 Percentage of participants
Interval 2.2 to 10.7
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
3.4 Percentage of participants
Interval 0.9 to 8.5
|
5.3 Percentage of participants
Interval 2.0 to 11.1
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Diarrhea: Moderate
|
—
|
—
|
—
|
—
|
—
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Diarrhea: Severe
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Diarrhea: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened muscle pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened joint pain: Mild
|
—
|
—
|
—
|
—
|
—
|
8.4 Percentage of participants
Interval 4.3 to 14.5
|
9.2 Percentage of participants
Interval 4.8 to 15.5
|
6.1 Percentage of participants
Interval 2.5 to 12.1
|
6.0 Percentage of participants
Interval 2.4 to 11.9
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened joint pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
9.2 Percentage of participants
Interval 4.8 to 15.5
|
8.4 Percentage of participants
Interval 4.3 to 14.5
|
7.0 Percentage of participants
Interval 3.1 to 13.2
|
11.1 Percentage of participants
Interval 6.1 to 18.3
|
0.9 Percentage of participants
Interval 0.0 to 4.8
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened joint pain: Severe
|
—
|
—
|
—
|
—
|
—
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
New or worsened joint pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fever: >=38.0 degree C to 38.4 degree C
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.0 Percentage of participants
Interval 0.2 to 7.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fever: >38.4 degree C to 38.9 degree C
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.1 Percentage of participants
Interval 0.6 to 8.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fever: >38.9 degree C to 40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fever: >40.0 degree C
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fatigue: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.2 Percentage of participants
Interval 5.7 to 19.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fatigue: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.3 Percentage of participants
Interval 10.4 to 26.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fatigue: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Fatigue: grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Headache: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.2 Percentage of participants
Interval 6.5 to 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Headache: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.2 Percentage of participants
Interval 6.5 to 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Headache: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Headache: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Chills: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.2 Percentage of participants
Interval 3.6 to 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Chills: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.1 Percentage of participants
Interval 2.3 to 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Chills: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Chills: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Vomiting: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Vomiting: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Vomiting: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Vomiting: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Diarrhea: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.0 Percentage of participants
Interval 0.2 to 7.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Diarrhea: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Diarrhea: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: Diarrhea: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened muscle pain: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.1 Percentage of participants
Interval 2.3 to 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened muscle pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.1 Percentage of participants
Interval 2.3 to 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened muscle pain: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened muscle pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened joint pain: Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.1 Percentage of participants
Interval 1.1 to 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened joint pain: Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.1 Percentage of participants
Interval 1.1 to 10.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened joint pain: Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
Post vaccination 2: New or worsened joint pain: Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination to 4 weeks after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)Population: Safety population included all the participants who received the study intervention.
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. Only AEs collected by non-systematic assessment (i.e, excluding local reactions and systematic events) were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=131 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=131 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=116 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=117 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=15 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=16 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=115 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=117 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B
|
1.5 Percentage of participants
|
3.1 Percentage of participants
|
6.9 Percentage of participants
|
8.5 Percentage of participants
|
0 Percentage of participants
|
7.1 Percentage of participants
|
13.3 Percentage of participants
|
6.3 Percentage of participants
|
6.3 Percentage of participants
|
12.5 Percentage of participants
|
0 Percentage of participants
|
6.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.0 Percentage of participants
|
12.0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: From first vaccination to 6 month after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=131 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=131 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=116 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=117 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=15 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=16 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=115 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=117 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0.00 Percentage of participants
Interval 0.0 to 21.8
|
0.00 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
6.3 Percentage of participants
Interval 0.2 to 30.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
0.0 Percentage of participants
Interval 0.0 to 20.6
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 3.2
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
PRIMARY outcome
Timeframe: 2 days after vaccination 1Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 1 were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after vaccination 2Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination 2 were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after vaccinationPopulation: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Percentage of participants reporting abnormal troponin I laboratory values 2 days after vaccination were reported in this outcome measure.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=114 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after vaccination 1Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. 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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=13 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after vaccination 2Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. 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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=13 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after vaccination 1Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. 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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=16 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)Population: Safety population included all the participants who received the study intervention. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Twelve lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. 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 |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=114 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 1, 4 and 8 after vaccination 1Population: Vaccination 1 evaluable immunogenicity population (EIP) included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. 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\*LLQ.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=12 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=13 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=12 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=11 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=11 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=9 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=13 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=11 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=11 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B1
|
31.7 Titers
Interval 18.9 to 53.2
|
33.6 Titers
Interval 19.7 to 57.4
|
40.0 Titers
Interval 23.9 to 66.8
|
31.7 Titers
Interval 15.6 to 64.6
|
66.2 Titers
Interval 31.2 to 140.7
|
—
|
—
|
—
|
—
|
—
|
69.0 Titers
Interval 41.8 to 113.8
|
37.9 Titers
Interval 21.8 to 65.9
|
66.2 Titers
Interval 27.3 to 160.6
|
72.5 Titers
Interval 41.3 to 127.2
|
21.0 Titers
Interval 11.1 to 39.7
|
21.9 Titers
Interval 11.5 to 41.9
|
22.7 Titers
Interval 12.2 to 42.1
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B1
|
17.4 Titers
Interval 9.9 to 30.7
|
17.8 Titers
Interval 8.9 to 35.8
|
27.5 Titers
Interval 16.2 to 46.8
|
22.4 Titers
Interval 12.8 to 39.2
|
37.3 Titers
Interval 16.9 to 82.3
|
—
|
—
|
—
|
—
|
—
|
48.8 Titers
Interval 30.1 to 79.0
|
27.5 Titers
Interval 13.4 to 56.4
|
42.6 Titers
Interval 15.2 to 119.3
|
46.4 Titers
Interval 26.2 to 82.0
|
16.2 Titers
Interval 9.3 to 28.0
|
20.0 Titers
Interval 11.9 to 33.7
|
20.0 Titers
Interval 11.5 to 34.7
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
1 Week after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
160.0 Titers
Interval 112.6 to 227.3
|
87.7 Titers
Interval 49.2 to 156.4
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
88.3 Titers
Interval 51.4 to 151.7
|
57.9 Titers
Interval 43.5 to 77.0
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84.4 Titers
Interval 52.9 to 134.6
|
45.9 Titers
Interval 30.3 to 69.6
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
1 Week after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.8 Titers
Interval 8.3 to 19.7
|
24.1 Titers
Interval 15.4 to 37.6
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.2 Titers
Interval 9.8 to 30.5
|
31.7 Titers
Interval 17.9 to 56.4
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.5 Titers
Interval 8.8 to 24.0
|
23.0 Titers
Interval 14.5 to 36.5
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A1
|
115.8 Titers
Interval 68.8 to 194.8
|
108.8 Titers
Interval 42.6 to 278.1
|
89.0 Titers
Interval 50.7 to 156.3
|
95.1 Titers
Interval 57.6 to 157.1
|
197.0 Titers
Interval 61.1 to 634.6
|
70.5 Titers
Interval 30.0 to 165.7
|
137.1 Titers
Interval 46.2 to 406.7
|
117.6 Titers
Interval 52.6 to 262.8
|
162.8 Titers
Interval 64.5 to 411.0
|
68.2 Titers
Interval 34.3 to 135.6
|
—
|
—
|
—
|
—
|
104.4 Titers
Interval 46.4 to 235.2
|
133.0 Titers
Interval 71.3 to 248.1
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
1 Week after Vaccination 1: A1
|
115.8 Titers
Interval 73.4 to 182.6
|
75.5 Titers
Interval 33.0 to 172.9
|
68.2 Titers
Interval 43.2 to 107.7
|
127.0 Titers
Interval 69.4 to 232.2
|
80.0 Titers
Interval 44.4 to 144.2
|
51.5 Titers
Interval 20.6 to 128.4
|
80.0 Titers
Interval 28.6 to 223.8
|
63.5 Titers
Interval 21.2 to 190.4
|
80.0 Titers
Interval 28.7 to 223.2
|
40.0 Titers
Interval 20.9 to 76.7
|
—
|
—
|
—
|
—
|
69.0 Titers
Interval 39.9 to 119.3
|
100.8 Titers
Interval 47.0 to 216.2
|
—
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
1 Week after Vaccination 1: B1
|
24.1 Titers
Interval 15.4 to 37.6
|
20.0 Titers
Interval 10.7 to 37.3
|
32.3 Titers
Interval 20.3 to 51.4
|
42.4 Titers
Interval 26.3 to 68.3
|
35.3 Titers
Interval 19.0 to 65.4
|
—
|
—
|
—
|
—
|
—
|
37.9 Titers
Interval 22.4 to 64.2
|
22.3 Titers
Interval 12.7 to 39.1
|
29.2 Titers
Interval 17.3 to 49.4
|
56.6 Titers
Interval 37.6 to 85.1
|
19.0 Titers
Interval 10.7 to 33.9
|
17.4 Titers
Interval 11.0 to 27.7
|
29.2 Titers
Interval 14.9 to 57.1
|
|
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A1
|
192.5 Titers
Interval 120.4 to 307.8
|
137.1 Titers
Interval 66.4 to 283.0
|
129.3 Titers
Interval 70.8 to 236.0
|
134.5 Titers
Interval 68.1 to 265.7
|
287.9 Titers
Interval 120.3 to 689.1
|
109.6 Titers
Interval 41.9 to 287.0
|
205.4 Titers
Interval 65.0 to 649.2
|
186.6 Titers
Interval 98.4 to 354.1
|
314.0 Titers
Interval 117.2 to 841.1
|
122.6 Titers
Interval 56.5 to 266.0
|
—
|
—
|
—
|
—
|
176.7 Titers
Interval 84.8 to 368.0
|
204.6 Titers
Interval 106.0 to 395.1
|
—
|
SECONDARY outcome
Timeframe: Before vaccination to 1, 4 and 8 weeks after vaccination 1Population: Vaccination 1 evaluable immunogenicity population included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Geometric mean fold rise (GMFR) was defined as ratios of the results after vaccination to the results before vaccination. 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 prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=12 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=13 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=12 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=11 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=11 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=9 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=13 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=11 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=11 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.2 Fold Rise
Interval 1.0 to 1.6
|
1.6 Fold Rise
Interval 1.3 to 2.0
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A1
|
4.0 Fold Rise
Interval 2.3 to 7.0
|
4.8 Fold Rise
Interval 3.0 to 7.9
|
5.2 Fold Rise
Interval 2.8 to 9.8
|
3.0 Fold Rise
Interval 1.5 to 5.8
|
13.0 Fold Rise
Interval 3.4 to 49.8
|
2.7 Fold Rise
Interval 1.4 to 5.2
|
3.8 Fold Rise
Interval 2.0 to 7.3
|
4.0 Fold Rise
Interval 2.1 to 7.7
|
7.7 Fold Rise
Interval 4.1 to 14.7
|
3.1 Fold Rise
Interval 1.3 to 7.4
|
—
|
—
|
—
|
—
|
5.2 Fold Rise
Interval 3.2 to 8.6
|
5.5 Fold Rise
Interval 2.5 to 12.4
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: A1
|
4.0 Fold Rise
Interval 2.2 to 7.1
|
3.4 Fold Rise
Interval 2.0 to 5.6
|
3.8 Fold Rise
Interval 2.6 to 5.4
|
4.0 Fold Rise
Interval 2.1 to 7.7
|
5.5 Fold Rise
Interval 3.0 to 10.0
|
2.3 Fold Rise
Interval 1.4 to 3.7
|
2.7 Fold Rise
Interval 1.6 to 4.5
|
2.2 Fold Rise
Interval 1.2 to 3.8
|
4.7 Fold Rise
Interval 2.3 to 9.7
|
2.4 Fold Rise
Interval 1.3 to 4.3
|
—
|
—
|
—
|
—
|
4.4 Fold Rise
Interval 2.8 to 6.9
|
4.8 Fold Rise
Interval 2.4 to 9.7
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: B1
|
1.9 Fold Rise
Interval 1.5 to 2.5
|
1.8 Fold Rise
Interval 1.2 to 2.7
|
1.7 Fold Rise
Interval 1.3 to 2.2
|
2.2 Fold Rise
Interval 1.3 to 3.9
|
2.0 Fold Rise
Interval 1.2 to 3.3
|
—
|
—
|
—
|
—
|
—
|
1.8 Fold Rise
Interval 1.3 to 2.5
|
1.4 Fold Rise
Interval 1.0 to 1.8
|
1.8 Fold Rise
Interval 1.2 to 2.6
|
3.0 Fold Rise
Interval 1.9 to 4.7
|
1.6 Fold Rise
Interval 1.1 to 2.3
|
1.6 Fold Rise
Interval 1.1 to 2.3
|
2.1 Fold Rise
Interval 0.9 to 5.1
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.6 Fold Rise
Interval 1.6 to 4.1
|
1.4 Fold Rise
Interval 1.0 to 2.0
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A1
|
6.3 Fold Rise
Interval 3.5 to 11.5
|
6.5 Fold Rise
Interval 4.6 to 9.0
|
6.5 Fold Rise
Interval 3.2 to 13.2
|
4.5 Fold Rise
Interval 2.2 to 9.0
|
17.4 Fold Rise
Interval 6.4 to 47.0
|
4.0 Fold Rise
Interval 1.8 to 9.0
|
5.4 Fold Rise
Interval 3.0 to 9.8
|
4.0 Fold Rise
Interval 2.1 to 7.7
|
12.7 Fold Rise
Interval 6.6 to 24.4
|
3.8 Fold Rise
Interval 1.9 to 7.4
|
—
|
—
|
—
|
—
|
8.8 Fold Rise
Interval 5.4 to 14.5
|
7.4 Fold Rise
Interval 3.2 to 17.1
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B1
|
2.2 Fold Rise
Interval 1.6 to 3.0
|
2.4 Fold Rise
Interval 1.4 to 4.1
|
1.9 Fold Rise
Interval 1.0 to 3.5
|
1.9 Fold Rise
Interval 1.1 to 3.2
|
3.5 Fold Rise
Interval 1.6 to 7.6
|
—
|
—
|
—
|
—
|
—
|
3.6 Fold Rise
Interval 2.4 to 5.5
|
2.2 Fold Rise
Interval 1.7 to 3.0
|
4.5 Fold Rise
Interval 2.2 to 9.6
|
3.8 Fold Rise
Interval 2.5 to 5.8
|
1.7 Fold Rise
Interval 1.3 to 2.3
|
1.9 Fold Rise
Interval 1.2 to 3.1
|
2.1 Fold Rise
Interval 1.0 to 4.4
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.6 Fold Rise
Interval 1.1 to 2.4
|
1.8 Fold Rise
Interval 1.3 to 2.6
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.6 Fold Rise
Interval 2.6 to 8.4
|
2.3 Fold Rise
Interval 1.6 to 3.3
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B1
|
1.7 Fold Rise
Interval 1.1 to 2.4
|
1.7 Fold Rise
Interval 1.0 to 2.8
|
1.7 Fold Rise
Interval 1.1 to 2.7
|
1.4 Fold Rise
Interval 0.9 to 2.3
|
2.8 Fold Rise
Interval 1.2 to 6.4
|
—
|
—
|
—
|
—
|
—
|
2.6 Fold Rise
Interval 1.8 to 3.7
|
2.1 Fold Rise
Interval 1.4 to 3.3
|
2.9 Fold Rise
Interval 1.3 to 6.4
|
2.4 Fold Rise
Interval 1.6 to 3.6
|
1.4 Fold Rise
Interval 1.1 to 1.7
|
1.9 Fold Rise
Interval 1.3 to 2.9
|
1.6 Fold Rise
Interval 0.8 to 3.4
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.4 Fold Rise
Interval 0.9 to 2.1
|
1.4 Fold Rise
Interval 1.1 to 1.9
|
—
|
|
Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.3 Fold Rise
Interval 1.0 to 5.5
|
1.2 Fold Rise
Interval 0.7 to 2.0
|
—
|
SECONDARY outcome
Timeframe: At 1, 4 and 8 Weeks after vaccination 1Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after Vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before Vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified row.
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.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=12 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=13 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=12 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=11 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=11 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=9 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=13 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=11 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=10 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
—
|
—
|
—
|
—
|
—
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: A1
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
76.9 Percentage of participants
Interval 46.2 to 95.0
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
71.4 Percentage of participants
Interval 41.9 to 91.6
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: B1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A1
|
86.7 Percentage of participants
Interval 59.5 to 98.3
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
76.9 Percentage of participants
Interval 46.2 to 95.0
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
66.7 Percentage of participants
Interval 29.9 to 92.5
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
53.8 Percentage of participants
Interval 25.1 to 80.8
|
—
|
—
|
—
|
—
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B1
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
—
|
—
|
—
|
—
|
—
|
78.6 Percentage of participants
Interval 49.2 to 95.3
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
57.1 Percentage of participants
Interval 28.9 to 82.3
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A1
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
76.9 Percentage of participants
Interval 46.2 to 95.0
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
66.7 Percentage of participants
Interval 29.9 to 92.5
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
—
|
—
|
—
|
—
|
76.9 Percentage of participants
Interval 46.2 to 95.0
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
46.2 Percentage of participants
Interval 19.2 to 74.9
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
SECONDARY outcome
Timeframe: Before vaccination 1 on day 1 and 1, 4 and 8 weeks after vaccination 1Population: Vaccination 1 EIP=all eligible participants who received vaccination (vax) 1; had blood drawn for assay testing within specified time frame (26-35 days) after vax 1; had at least 1 valid and determinate assay result at 4-week post-vax 1 visit and had no major protocol deviations before vax 2. Number Analyzed=number of participants evaluable for specified rows and all participants in 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
Percentage of participants with HAI titer \>=1:40 for each strain before vaccination 1 and at 1, 4 and 8 weeks after vaccination 1 is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=15 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=12 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=13 Participants
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=12 Participants
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=11 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=11 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=9 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=13 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=11 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 Participants
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=11 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Prior to Vaccination 1: B1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
—
|
—
|
—
|
—
|
—
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Prior to Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: A1
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
66.7 Percentage of participants
Interval 29.9 to 92.5
|
76.9 Percentage of participants
Interval 46.2 to 95.0
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
—
|
—
|
—
|
—
|
78.6 Percentage of participants
Interval 49.2 to 95.3
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B1
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
61.5 Percentage of participants
Interval 31.6 to 86.1
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
72.7 Percentage of participants
Interval 39.0 to 94.0
|
—
|
—
|
—
|
—
|
—
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
61.5 Percentage of participants
Interval 31.6 to 86.1
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
85.7 Percentage of participants
Interval 57.2 to 98.2
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A1
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
100.0 Percentage of participants
Interval 75.3 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
88.9 Percentage of participants
Interval 51.8 to 99.7
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
76.9 Percentage of participants
Interval 46.2 to 95.0
|
—
|
—
|
—
|
—
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B1
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
—
|
—
|
—
|
—
|
—
|
78.6 Percentage of participants
Interval 49.2 to 95.3
|
61.5 Percentage of participants
Interval 31.6 to 86.1
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
71.4 Percentage of participants
Interval 41.9 to 91.6
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 75.3 to 100.0
|
86.7 Percentage of participants
Interval 59.5 to 98.3
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
8 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Prior to Vaccination 1: A1
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
55.6 Percentage of participants
Interval 21.2 to 86.3
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
46.2 Percentage of participants
Interval 19.2 to 74.9
|
—
|
—
|
—
|
—
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
Prior to Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
73.3 Percentage of participants
Interval 44.9 to 92.2
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: B1
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
46.2 Percentage of participants
Interval 19.2 to 74.9
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
—
|
—
|
—
|
—
|
—
|
61.5 Percentage of participants
Interval 31.6 to 86.1
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
85.7 Percentage of participants
Interval 57.2 to 98.2
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
1 Week after Vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 76.8 to 100.0
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: A1
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 75.3 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
81.8 Percentage of participants
Interval 48.2 to 97.7
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
—
|
—
|
—
|
—
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
—
|
|
Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
4 Weeks after Vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
—
|
SECONDARY outcome
Timeframe: At 1, 4, and 8 weeks After vaccination 1Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. 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.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
1 Week after Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
4 Weeks after Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
8 Weeks after Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination 1 on day 1 and 1, 4, and 8 weeks after vaccination 1Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before vaccination 2. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Percentage of participants with HAI titer \>=1:40 for all strains before vaccination 1 and 1, 4 and 8 weeks after vaccination 1 is presented in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
Prior to Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
1 Week after Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
4 Weeks after Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
8 Weeks after Vaccination 1
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks After vaccination 1Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after Vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before Vaccination 2.
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) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between vaccine groups, using licensed QIV group as reference and were reported in the statistical analysis section.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
A1
|
—
|
—
|
—
|
—
|
—
|
176.7 Titers
Interval 84.8 to 368.0
|
204.6 Titers
Interval 106.0 to 395.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
A2
|
—
|
—
|
—
|
—
|
—
|
88.3 Titers
Interval 51.4 to 151.7
|
57.9 Titers
Interval 43.5 to 77.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
|
Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
B1
|
—
|
—
|
—
|
—
|
—
|
21.0 Titers
Interval 11.1 to 39.7
|
21.9 Titers
Interval 11.5 to 41.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
B2
|
—
|
—
|
—
|
—
|
—
|
17.2 Titers
Interval 9.8 to 30.5
|
31.7 Titers
Interval 17.9 to 56.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 4 weeks after vaccination 1Population: Vaccination 1 EIP included all eligible participants who received vaccination 1; had blood drawn for assay testing within the specified time frame (26-35 days) after Vaccination 1; had at least 1 valid and determinate assay result at the 4-week post-vaccination 1 visit and had no major protocol deviations before Vaccination 2.
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. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination 1 and exact 2-sided 95% CI based on the Clopper and Pearson method is presented in the descriptive section. Difference in percentage of participants achieving HAI seroconversion for each strain at 4 weeks after vaccination 1 is presented in the statistical analysis section.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
A1
|
—
|
—
|
—
|
—
|
—
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
A2
|
—
|
—
|
—
|
—
|
—
|
57.1 Percentage of participants
Interval 28.9 to 82.3
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
B1
|
—
|
—
|
—
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
B2
|
—
|
—
|
—
|
—
|
—
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Before vaccination 1, 2 and, 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last 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.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=105 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=110 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=108 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=25 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
1 week after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
22.7 Titers
Interval 18.8 to 27.3
|
24.0 Titers
Interval 19.9 to 28.8
|
44.2 Titers
Interval 36.4 to 53.6
|
17.9 Titers
Interval 12.0 to 26.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
4 weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
121.0 Titers
Interval 96.5 to 151.7
|
155.7 Titers
Interval 122.9 to 197.2
|
126.4 Titers
Interval 97.8 to 163.5
|
143.2 Titers
Interval 87.4 to 234.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
4 weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
99.7 Titers
Interval 83.8 to 118.6
|
108.7 Titers
Interval 95.8 to 123.4
|
69.0 Titers
Interval 57.9 to 82.3
|
102.7 Titers
Interval 64.4 to 163.7
|
—
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
4 weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
33.0 Titers
Interval 28.2 to 38.7
|
36.4 Titers
Interval 30.4 to 43.5
|
57.7 Titers
Interval 47.3 to 70.3
|
32.9 Titers
Interval 21.7 to 50.0
|
—
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
4 weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
23.7 Titers
Interval 19.9 to 28.1
|
26.9 Titers
Interval 22.6 to 32.1
|
49.6 Titers
Interval 40.3 to 61.1
|
15.6 Titers
Interval 10.5 to 23.1
|
—
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
8 weeks after vaccination: A1
|
—
|
—
|
—
|
—
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—
|
128.4 Titers
Interval 101.8 to 161.8
|
128.3 Titers
Interval 100.6 to 163.8
|
81.7 Titers
Interval 62.9 to 106.1
|
157.0 Titers
Interval 99.5 to 247.8
|
—
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
8 weeks after vaccination: A2
|
—
|
—
|
—
|
—
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—
|
95.5 Titers
Interval 79.9 to 114.1
|
101.7 Titers
Interval 84.6 to 122.1
|
34.3 Titers
Interval 27.8 to 42.3
|
67.7 Titers
Interval 43.3 to 105.9
|
—
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
8 weeks after vaccination: B1
|
—
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—
|
—
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—
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—
|
20.4 Titers
Interval 17.1 to 24.3
|
22.6 Titers
Interval 18.2 to 28.0
|
30.0 Titers
Interval 23.9 to 37.6
|
26.4 Titers
Interval 18.1 to 38.5
|
—
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—
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—
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—
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—
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—
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—
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—
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
8 weeks after vaccination: B2
|
—
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—
|
—
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—
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—
|
17.5 Titers
Interval 14.5 to 21.2
|
19.4 Titers
Interval 16.2 to 23.2
|
32.4 Titers
Interval 26.8 to 39.3
|
15.2 Titers
Interval 10.7 to 21.5
|
—
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 1: A1
|
—
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—
|
—
|
—
|
—
|
26.7 Titers
Interval 21.3 to 33.5
|
26.9 Titers
Interval 21.1 to 34.4
|
27.3 Titers
Interval 21.8 to 34.2
|
16.3 Titers
Interval 10.3 to 25.9
|
—
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—
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—
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—
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—
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—
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—
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—
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 1: A2
|
—
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—
|
—
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—
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—
|
35.9 Titers
Interval 30.0 to 43.1
|
27.9 Titers
Interval 23.2 to 33.6
|
29.3 Titers
Interval 24.5 to 35.1
|
10.0 Titers
Interval 6.6 to 15.1
|
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—
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—
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—
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—
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—
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—
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—
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|
HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 1: B1
|
—
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—
|
—
|
—
|
—
|
20.3 Titers
Interval 17.1 to 24.0
|
20.0 Titers
Interval 16.8 to 23.8
|
20.7 Titers
Interval 17.3 to 24.7
|
8.4 Titers
Interval 6.1 to 11.6
|
—
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—
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—
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—
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—
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—
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—
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—
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 1: B2
|
—
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—
|
—
|
—
|
—
|
17.0 Titers
Interval 14.4 to 20.0
|
17.5 Titers
Interval 14.6 to 20.9
|
16.2 Titers
Interval 13.8 to 19.0
|
8.4 Titers
Interval 6.1 to 11.5
|
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—
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—
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—
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—
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—
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—
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—
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 2: A1
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108.5 Titers
Interval 67.0 to 175.8
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 2: A2
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75.7 Titers
Interval 47.8 to 119.8
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 2: B1
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18.4 Titers
Interval 12.4 to 27.4
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
Prior to vaccination 2: B2
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12.5 Titers
Interval 8.7 to 18.0
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
1 week after vaccination: A1
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76.7 Titers
Interval 60.5 to 97.3
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88.2 Titers
Interval 69.1 to 112.5
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99.0 Titers
Interval 77.6 to 126.3
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151.4 Titers
Interval 96.3 to 237.8
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
1 week after vaccination: A2
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68.1 Titers
Interval 57.5 to 80.7
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62.8 Titers
Interval 51.9 to 75.9
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59.0 Titers
Interval 50.0 to 69.7
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82.2 Titers
Interval 54.2 to 124.8
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HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
1 week after vaccination: B1
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30.7 Titers
Interval 26.0 to 36.4
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30.3 Titers
Interval 25.0 to 36.7
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48.9 Titers
Interval 40.3 to 59.2
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26.4 Titers
Interval 18.1 to 38.5
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SECONDARY outcome
Timeframe: Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last 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.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=12 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=10 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=10 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=11 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=12 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
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SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
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SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 1: A2
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21.0 Titers
Interval 13.0 to 33.8
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32.1 Titers
Interval 16.2 to 63.4
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50.9 Titers
Interval 37.1 to 69.9
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26.9 Titers
Interval 14.2 to 51.1
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28.5 Titers
Interval 15.9 to 51.1
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36.6 Titers
Interval 22.7 to 59.1
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66.0 Titers
Interval 35.4 to 122.9
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35.5 Titers
Interval 20.7 to 60.7
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45.8 Titers
Interval 33.5 to 62.6
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20.1 Titers
Interval 10.7 to 37.8
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19.6 Titers
Interval 10.7 to 35.8
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
1 week after last vaccination: B1
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28.3 Titers
Interval 15.0 to 53.5
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45.9 Titers
Interval 22.1 to 95.5
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42.9 Titers
Interval 24.8 to 74.0
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66.2 Titers
Interval 39.6 to 110.7
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67.3 Titers
Interval 45.9 to 98.5
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35.6 Titers
Interval 23.6 to 53.9
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63.5 Titers
Interval 29.1 to 138.8
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18.2 Titers
Interval 11.1 to 30.1
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36.2 Titers
Interval 22.7 to 57.8
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23.5 Titers
Interval 13.3 to 41.5
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36.5 Titers
Interval 20.8 to 63.8
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
4 weeks after last vaccination: A1
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332.1 Titers
Interval 161.7 to 682.3
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411.9 Titers
Interval 165.5 to 1025.6
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422.2 Titers
Interval 225.5 to 790.6
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320.0 Titers
Interval 160.4 to 638.4
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160.0 Titers
Interval 73.8 to 347.0
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239.7 Titers
Interval 138.8 to 413.9
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338.4 Titers
Interval 179.5 to 638.0
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335.1 Titers
Interval 196.8 to 570.7
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88.3 Titers
Interval 42.4 to 184.0
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178.0 Titers
Interval 80.0 to 395.9
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—
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164.8 Titers
Interval 81.0 to 335.6
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
4 weeks after last vaccination: B1
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151.0 Titers
Interval 87.5 to 260.8
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45.9 Titers
Interval 17.6 to 119.8
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42.9 Titers
Interval 26.2 to 70.2
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58.4 Titers
Interval 32.0 to 106.6
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63.5 Titers
Interval 36.9 to 109.2
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63.5 Titers
Interval 41.2 to 98.0
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80.0 Titers
Interval 35.3 to 181.4
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38.2 Titers
Interval 22.9 to 63.7
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40.0 Titers
Interval 26.4 to 60.6
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104.4 Titers
Interval 65.3 to 167.0
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76.4 Titers
Interval 56.2 to 103.8
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
4 weeks after last vaccination: A2
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37.8 Titers
Interval 21.2 to 67.3
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130.0 Titers
Interval 86.4 to 195.5
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171.5 Titers
Interval 99.4 to 295.9
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124.4 Titers
Interval 80.9 to 191.3
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119.9 Titers
Interval 80.6 to 178.2
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95.1 Titers
Interval 59.8 to 151.4
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254.0 Titers
Interval 171.8 to 375.5
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145.9 Titers
Interval 102.7 to 207.3
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62.5 Titers
Interval 41.7 to 93.5
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23.5 Titers
Interval 13.3 to 41.5
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48.8 Titers
Interval 26.3 to 90.3
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
8 weeks after last vaccination: A1
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370.4 Titers
Interval 162.0 to 847.0
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298.6 Titers
Interval 135.4 to 658.5
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211.1 Titers
Interval 130.8 to 340.9
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170.4 Titers
Interval 84.2 to 344.8
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75.5 Titers
Interval 36.1 to 158.0
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151.0 Titers
Interval 80.0 to 285.2
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248.7 Titers
Interval 104.7 to 591.0
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175.5 Titers
Interval 95.0 to 324.0
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51.2 Titers
Interval 25.6 to 102.7
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198.0 Titers
Interval 86.6 to 452.8
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176.7 Titers
Interval 86.3 to 361.8
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 1: A1
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—
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50.6 Titers
Interval 18.3 to 140.3
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25.2 Titers
Interval 10.6 to 59.7
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46.5 Titers
Interval 17.6 to 122.5
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27.4 Titers
Interval 12.8 to 58.7
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26.3 Titers
Interval 13.1 to 53.1
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23.4 Titers
Interval 10.6 to 51.9
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70.3 Titers
Interval 29.2 to 168.8
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27.5 Titers
Interval 14.9 to 51.0
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24.3 Titers
Interval 11.3 to 52.2
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32.3 Titers
Interval 15.8 to 65.9
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—
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39.9 Titers
Interval 14.2 to 111.9
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 1: B1
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—
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13.0 Titers
Interval 6.7 to 25.5
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16.5 Titers
Interval 9.7 to 28.1
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20.8 Titers
Interval 14.3 to 30.3
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24.7 Titers
Interval 11.6 to 52.4
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16.7 Titers
Interval 8.8 to 31.7
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19.3 Titers
Interval 13.9 to 26.6
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25.9 Titers
Interval 15.8 to 42.4
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13.7 Titers
Interval 8.9 to 21.1
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22.9 Titers
Interval 14.8 to 35.5
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11.0 Titers
Interval 6.4 to 19.0
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—
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—
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18.4 Titers
Interval 9.4 to 36.0
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 1: B2
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—
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—
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15.7 Titers
Interval 7.8 to 31.5
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14.5 Titers
Interval 10.6 to 19.7
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16.6 Titers
Interval 9.8 to 28.2
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13.1 Titers
Interval 7.0 to 24.6
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17.7 Titers
Interval 8.4 to 37.5
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14.4 Titers
Interval 9.2 to 22.7
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18.2 Titers
Interval 11.1 to 29.7
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9.1 Titers
Interval 6.7 to 12.3
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12.5 Titers
Interval 9.8 to 16.1
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10.5 Titers
Interval 6.1 to 18.3
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—
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—
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11.6 Titers
Interval 7.1 to 18.8
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 2: A1
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394.0 Titers
Interval 164.0 to 946.2
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298.6 Titers
Interval 145.5 to 612.5
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219.3 Titers
Interval 99.6 to 482.7
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160.0 Titers
Interval 70.6 to 362.8
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 2: A2
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—
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149.3 Titers
Interval 75.7 to 294.5
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69.6 Titers
Interval 32.3 to 150.1
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66.2 Titers
Interval 35.3 to 124.1
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95.1 Titers
Interval 55.7 to 162.5
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 2: B1
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—
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34.8 Titers
Interval 18.9 to 64.1
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42.9 Titers
Interval 22.7 to 81.1
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75.1 Titers
Interval 38.3 to 147.3
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63.5 Titers
Interval 41.2 to 98.0
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
Prior to Vaccination 2: B2
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—
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23.0 Titers
Interval 13.1 to 40.3
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42.9 Titers
Interval 20.1 to 91.3
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33.1 Titers
Interval 16.5 to 66.2
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89.8 Titers
Interval 43.6 to 185.1
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
1 Week after last vaccination: A1
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—
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151.0 Titers
Interval 63.3 to 360.4
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569.7 Titers
Interval 291.3 to 1114.1
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320.0 Titers
Interval 165.2 to 619.8
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320.0 Titers
Interval 165.6 to 618.2
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160.0 Titers
Interval 77.3 to 331.1
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151.0 Titers
Interval 97.4 to 234.2
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326.0 Titers
Interval 171.5 to 619.6
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96.2 Titers
Interval 60.2 to 153.9
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72.5 Titers
Interval 35.4 to 148.4
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134.5 Titers
Interval 52.5 to 344.9
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—
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121.3 Titers
Interval 57.2 to 257.0
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
1 week after vaccination: A2
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—
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56.6 Titers
Interval 28.4 to 112.8
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171.5 Titers
Interval 90.6 to 324.6
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113.1 Titers
Interval 60.3 to 212.3
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90.7 Titers
Interval 54.9 to 150.0
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75.5 Titers
Interval 37.0 to 154.2
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84.8 Titers
Interval 54.7 to 131.4
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151.0 Titers
Interval 82.3 to 277.2
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96.2 Titers
Interval 68.6 to 135.1
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88.3 Titers
Interval 58.6 to 133.2
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113.1 Titers
Interval 56.7 to 225.6
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—
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—
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45.9 Titers
Interval 33.0 to 64.0
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
1 week after last vaccination: B2
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—
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—
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—
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23.8 Titers
Interval 11.2 to 50.6
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26.4 Titers
Interval 12.5 to 55.7
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40.0 Titers
Interval 19.1 to 83.8
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33.1 Titers
Interval 16.5 to 66.2
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75.5 Titers
Interval 38.9 to 146.5
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31.7 Titers
Interval 21.5 to 46.9
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44.9 Titers
Interval 25.7 to 78.5
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12.6 Titers
Interval 8.9 to 17.8
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25.6 Titers
Interval 11.9 to 54.9
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16.2 Titers
Interval 9.6 to 27.3
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—
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—
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20.0 Titers
Interval 12.9 to 30.9
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
4 weeks after last vaccination: B2
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—
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—
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—
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—
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26.7 Titers
Interval 15.0 to 47.6
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21.4 Titers
Interval 10.1 to 45.6
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32.5 Titers
Interval 16.7 to 63.1
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22.7 Titers
Interval 14.4 to 35.8
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56.6 Titers
Interval 29.1 to 109.9
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42.4 Titers
Interval 23.8 to 75.5
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42.4 Titers
Interval 23.8 to 75.5
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18.2 Titers
Interval 10.2 to 32.5
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31.2 Titers
Interval 14.6 to 67.0
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15.3 Titers
Interval 8.4 to 28.1
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—
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20.0 Titers
Interval 12.5 to 32.0
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HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
8 weeks after last vaccination: B2
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—
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—
|
—
|
26.7 Titers
Interval 14.1 to 50.4
|
21.4 Titers
Interval 8.8 to 52.1
|
28.3 Titers
Interval 12.5 to 64.1
|
22.7 Titers
Interval 10.5 to 49.2
|
56.6 Titers
Interval 29.9 to 106.9
|
33.6 Titers
Interval 19.7 to 57.4
|
45.4 Titers
Interval 22.2 to 92.8
|
18.2 Titers
Interval 9.6 to 34.8
|
23.2 Titers
Interval 11.9 to 45.3
|
15.3 Titers
Interval 8.2 to 28.7
|
—
|
—
|
19.0 Titers
Interval 11.9 to 30.3
|
|
HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
8 Week after last vaccination: B1
|
—
|
—
|
—
|
—
|
127.0 Titers
Interval 79.2 to 203.7
|
45.9 Titers
Interval 15.8 to 133.4
|
30.3 Titers
Interval 14.9 to 61.6
|
48.3 Titers
Interval 28.9 to 80.8
|
44.9 Titers
Interval 26.5 to 75.9
|
42.4 Titers
Interval 23.8 to 75.5
|
42.6 Titers
Interval 15.5 to 116.8
|
17.4 Titers
Interval 9.9 to 30.7
|
23.2 Titers
Interval 13.7 to 39.2
|
116.2 Titers
Interval 54.5 to 247.8
|
—
|
—
|
69.0 Titers
Interval 48.2 to 98.6
|
|
HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
8 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
37.8 Titers
Interval 19.0 to 75.2
|
149.3 Titers
Interval 82.5 to 270.3
|
105.6 Titers
Interval 65.4 to 170.4
|
105.6 Titers
Interval 65.4 to 170.4
|
63.5 Titers
Interval 34.7 to 116.1
|
90.7 Titers
Interval 60.4 to 136.3
|
181.5 Titers
Interval 109.8 to 299.9
|
96.2 Titers
Interval 47.7 to 194.4
|
31.2 Titers
Interval 17.9 to 54.5
|
23.5 Titers
Interval 12.3 to 44.7
|
—
|
—
|
48.8 Titers
Interval 25.3 to 93.9
|
SECONDARY outcome
Timeframe: From before vaccination 2 to 1, 4, and 8 weeks after the last vaccinationPopulation: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last 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.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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 prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=105 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=110 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=108 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=25 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
2.6 Fold Rise
Interval 2.2 to 3.2
|
2.9 Fold Rise
Interval 2.4 to 3.5
|
3.3 Fold Rise
Interval 2.6 to 4.1
|
7.6 Fold Rise
Interval 4.4 to 12.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
1.5 Fold Rise
Interval 1.3 to 1.6
|
1.4 Fold Rise
Interval 1.3 to 1.6
|
2.2 Fold Rise
Interval 1.8 to 2.6
|
2.2 Fold Rise
Interval 1.5 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
1.8 Fold Rise
Interval 1.5 to 2.1
|
2.1 Fold Rise
Interval 1.7 to 2.5
|
1.9 Fold Rise
Interval 1.7 to 2.2
|
6.0 Fold Rise
Interval 4.0 to 9.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.3 Fold Rise
Interval 1.2 to 1.4
|
1.3 Fold Rise
Interval 1.1 to 1.4
|
2.4 Fold Rise
Interval 1.9 to 3.0
|
1.5 Fold Rise
Interval 1.1 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
4.0 Fold Rise
Interval 3.2 to 5.0
|
4.9 Fold Rise
Interval 3.9 to 6.2
|
4.1 Fold Rise
Interval 3.2 to 5.3
|
7.1 Fold Rise
Interval 4.2 to 12.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
1.5 Fold Rise
Interval 1.4 to 1.7
|
1.7 Fold Rise
Interval 1.5 to 2.0
|
2.7 Fold Rise
Interval 2.2 to 3.3
|
2.7 Fold Rise
Interval 1.8 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
2.6 Fold Rise
Interval 2.2 to 3.0
|
3.5 Fold Rise
Interval 3.0 to 4.0
|
2.3 Fold Rise
Interval 1.9 to 2.7
|
7.8 Fold Rise
Interval 5.1 to 11.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.3 Fold Rise
Interval 1.2 to 1.4
|
1.4 Fold Rise
Interval 1.2 to 1.6
|
2.8 Fold Rise
Interval 2.2 to 3.5
|
1.4 Fold Rise
Interval 1.1 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
4.3 Fold Rise
Interval 3.5 to 5.2
|
4.0 Fold Rise
Interval 3.2 to 5.0
|
2.7 Fold Rise
Interval 2.1 to 3.5
|
7.8 Fold Rise
Interval 4.8 to 12.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
2.5 Fold Rise
Interval 2.1 to 3.0
|
3.3 Fold Rise
Interval 2.7 to 4.0
|
1.1 Fold Rise
Interval 0.9 to 1.4
|
5.0 Fold Rise
Interval 3.3 to 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
1.1 Fold Rise
Interval 0.9 to 1.3
|
1.4 Fold Rise
Interval 1.1 to 1.7
|
2.2 Fold Rise
Interval 1.6 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.0 Fold Rise
Interval 0.8 to 1.1
|
1.0 Fold Rise
Interval 0.9 to 1.1
|
1.8 Fold Rise
Interval 1.5 to 2.2
|
1.4 Fold Rise
Interval 1.1 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to Vaccination 2: A1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.3 Fold Rise
Interval 3.4 to 8.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to Vaccination 2: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.5 Fold Rise
Interval 3.6 to 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to Vaccination 2: B1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.6 Fold Rise
Interval 1.2 to 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to Vaccination 2: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.2 Fold Rise
Interval 0.9 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From before vaccination 1 to prior to vaccination 2, 1, 4, and 8 weeks after the last vaccination (i.e., vaccination 1 and 2 for 1-visit schedule and 2 visit schedule, respectively)Population: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last 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.Here,'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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 prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the prevaccination assay results were set to LLOQ for the GMFR calculation.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=12 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=10 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=10 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=11 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=12 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=12 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=14 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: A1
|
—
|
—
|
—
|
—
|
2.8 Fold Rise
Interval 1.5 to 5.3
|
24.8 Fold Rise
Interval 8.9 to 68.7
|
7.0 Fold Rise
Interval 2.8 to 17.6
|
10.3 Fold Rise
Interval 5.0 to 21.3
|
6.0 Fold Rise
Interval 2.2 to 16.3
|
6.0 Fold Rise
Interval 3.2 to 11.3
|
4.8 Fold Rise
Interval 1.8 to 13.3
|
3.6 Fold Rise
Interval 2.1 to 6.4
|
2.8 Fold Rise
Interval 1.3 to 6.0
|
3.6 Fold Rise
Interval 2.2 to 5.8
|
—
|
—
|
2.6 Fold Rise
Interval 1.6 to 4.3
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: A1
|
—
|
—
|
—
|
—
|
—
|
17.1 Fold Rise
Interval 6.1 to 48.1
|
6.5 Fold Rise
Interval 2.2 to 19.0
|
7.1 Fold Rise
Interval 2.6 to 19.1
|
6.0 Fold Rise
Interval 2.0 to 17.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: A2
|
—
|
—
|
—
|
—
|
—
|
5.7 Fold Rise
Interval 3.0 to 10.6
|
2.5 Fold Rise
Interval 1.3 to 4.8
|
2.9 Fold Rise
Interval 1.5 to 5.7
|
4.2 Fold Rise
Interval 2.0 to 8.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: B1
|
—
|
—
|
—
|
—
|
—
|
1.7 Fold Rise
Interval 1.1 to 2.7
|
2.0 Fold Rise
Interval 1.3 to 3.2
|
2.9 Fold Rise
Interval 1.4 to 6.2
|
3.2 Fold Rise
Interval 1.7 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: B1
|
—
|
—
|
—
|
—
|
1.8 Fold Rise
Interval 1.2 to 2.6
|
2.3 Fold Rise
Interval 1.4 to 3.8
|
2.0 Fold Rise
Interval 1.4 to 2.8
|
2.6 Fold Rise
Interval 1.4 to 4.9
|
3.4 Fold Rise
Interval 2.0 to 5.6
|
2.0 Fold Rise
Interval 1.4 to 2.9
|
2.7 Fold Rise
Interval 1.6 to 4.5
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
1.5 Fold Rise
Interval 1.0 to 2.3
|
1.6 Fold Rise
Interval 1.2 to 2.1
|
—
|
—
|
1.5 Fold Rise
Interval 1.2 to 1.8
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: A2
|
—
|
—
|
—
|
—
|
2.4 Fold Rise
Interval 1.4 to 4.1
|
6.5 Fold Rise
Interval 3.2 to 13.1
|
4.0 Fold Rise
Interval 2.5 to 6.4
|
4.0 Fold Rise
Interval 2.2 to 7.2
|
3.6 Fold Rise
Interval 1.8 to 7.2
|
1.7 Fold Rise
Interval 1.1 to 2.7
|
2.5 Fold Rise
Interval 1.0 to 6.4
|
2.3 Fold Rise
Interval 1.7 to 3.1
|
1.6 Fold Rise
Interval 0.9 to 2.7
|
4.8 Fold Rise
Interval 2.3 to 9.6
|
—
|
—
|
2.0 Fold Rise
Interval 1.3 to 3.1
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
1.5 Fold Rise
Interval 1.0 to 2.3
|
1.7 Fold Rise
Interval 0.9 to 3.2
|
2.1 Fold Rise
Interval 1.2 to 3.7
|
1.5 Fold Rise
Interval 0.9 to 2.3
|
2.7 Fold Rise
Interval 1.4 to 5.2
|
2.7 Fold Rise
Interval 1.3 to 5.6
|
2.4 Fold Rise
Interval 1.3 to 4.4
|
1.8 Fold Rise
Interval 1.2 to 2.8
|
2.1 Fold Rise
Interval 1.0 to 4.5
|
1.2 Fold Rise
Interval 0.9 to 1.5
|
—
|
—
|
1.3 Fold Rise
Interval 0.9 to 1.8
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
2.2 Fold Rise
Interval 1.3 to 3.9
|
3.2 Fold Rise
Interval 1.7 to 6.3
|
2.1 Fold Rise
Interval 1.6 to 2.8
|
2.3 Fold Rise
Interval 1.1 to 4.6
|
3.2 Fold Rise
Interval 1.7 to 6.0
|
3.2 Fold Rise
Interval 1.7 to 6.0
|
3.0 Fold Rise
Interval 1.5 to 6.0
|
2.5 Fold Rise
Interval 1.5 to 4.2
|
1.7 Fold Rise
Interval 1.2 to 2.5
|
1.7 Fold Rise
Interval 1.1 to 2.6
|
—
|
—
|
1.9 Fold Rise
Interval 1.4 to 2.7
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
7.6 Fold Rise
Interval 3.7 to 15.4
|
3.5 Fold Rise
Interval 1.7 to 7.0
|
2.5 Fold Rise
Interval 1.8 to 3.4
|
3.5 Fold Rise
Interval 2.1 to 5.8
|
3.0 Fold Rise
Interval 1.8 to 5.0
|
3.8 Fold Rise
Interval 2.3 to 6.1
|
3.8 Fold Rise
Interval 2.3 to 6.3
|
4.4 Fold Rise
Interval 2.6 to 7.4
|
1.9 Fold Rise
Interval 1.2 to 3.1
|
5.0 Fold Rise
Interval 3.2 to 7.6
|
—
|
—
|
3.3 Fold Rise
Interval 2.1 to 5.2
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
6.0 Fold Rise
Interval 2.2 to 15.8
|
13.0 Fold Rise
Interval 4.7 to 36.0
|
4.6 Fold Rise
Interval 2.0 to 10.6
|
5.5 Fold Rise
Interval 2.7 to 11.1
|
2.8 Fold Rise
Interval 1.1 to 7.3
|
6.0 Fold Rise
Interval 2.6 to 14.0
|
3.3 Fold Rise
Interval 1.1 to 10.4
|
6.6 Fold Rise
Interval 2.6 to 17.1
|
2.0 Fold Rise
Interval 1.1 to 3.7
|
5.8 Fold Rise
Interval 2.9 to 11.7
|
—
|
—
|
4.0 Fold Rise
Interval 2.0 to 8.1
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
5.0 Fold Rise
Interval 2.7 to 9.5
|
5.7 Fold Rise
Interval 2.8 to 11.5
|
3.7 Fold Rise
Interval 2.4 to 5.8
|
5.7 Fold Rise
Interval 3.3 to 9.7
|
3.0 Fold Rise
Interval 1.7 to 5.3
|
1.9 Fold Rise
Interval 1.1 to 3.3
|
2.1 Fold Rise
Interval 0.9 to 5.1
|
2.3 Fold Rise
Interval 1.1 to 4.9
|
0.6 Fold Rise
Interval 0.3 to 1.0
|
5.0 Fold Rise
Interval 2.4 to 10.3
|
—
|
—
|
3.1 Fold Rise
Interval 2.0 to 4.9
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
2.4 Fold Rise
Interval 1.5 to 3.8
|
2.5 Fold Rise
Interval 1.1 to 5.5
|
1.4 Fold Rise
Interval 0.9 to 2.2
|
1.9 Fold Rise
Interval 1.1 to 3.3
|
2.2 Fold Rise
Interval 1.3 to 3.8
|
2.5 Fold Rise
Interval 1.2 to 5.1
|
1.8 Fold Rise
Interval 0.7 to 4.2
|
1.0 Fold Rise
Interval 0.7 to 1.6
|
1.0 Fold Rise
Interval 0.6 to 1.5
|
1.6 Fold Rise
Interval 1.2 to 2.2
|
—
|
—
|
2.2 Fold Rise
Interval 1.5 to 3.4
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
1.4 Fold Rise
Interval 1.1 to 1.9
|
1.3 Fold Rise
Interval 0.6 to 3.1
|
1.5 Fold Rise
Interval 0.8 to 3.0
|
1.6 Fold Rise
Interval 0.9 to 2.8
|
2.5 Fold Rise
Interval 1.3 to 4.9
|
2.1 Fold Rise
Interval 1.1 to 4.2
|
2.4 Fold Rise
Interval 1.1 to 5.3
|
1.7 Fold Rise
Interval 0.9 to 3.0
|
2.2 Fold Rise
Interval 1.2 to 4.1
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
—
|
—
|
1.6 Fold Rise
Interval 1.1 to 2.3
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: B2
|
—
|
—
|
—
|
—
|
1.4 Fold Rise
Interval 1.0 to 2.0
|
1.6 Fold Rise
Interval 0.8 to 3.2
|
2.0 Fold Rise
Interval 1.1 to 3.7
|
2.1 Fold Rise
Interval 1.2 to 3.9
|
3.4 Fold Rise
Interval 1.7 to 6.6
|
1.9 Fold Rise
Interval 1.2 to 2.9
|
2.1 Fold Rise
Interval 2.1 to 3.3
|
1.2 Fold Rise
Interval 1.0 to 1.5
|
2.4 Fold Rise
Interval 1.2 to 4.9
|
1.2 Fold Rise
Interval 0.9 to 1.6
|
—
|
—
|
1.4 Fold Rise
Interval 1.0 to 1.9
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
6.6 Fold Rise
Interval 2.7 to 16.1
|
14.6 Fold Rise
Interval 5.1 to 41.8
|
8.0 Fold Rise
Interval 3.0 to 21.6
|
10.3 Fold Rise
Interval 5.5 to 19.4
|
5.3 Fold Rise
Interval 2.0 to 14.0
|
8.0 Fold Rise
Interval 3.1 to 20.8
|
4.7 Fold Rise
Interval 1.8 to 12.6
|
10.1 Fold Rise
Interval 4.9 to 20.7
|
3.0 Fold Rise
Interval 1.5 to 5.9
|
5.2 Fold Rise
Interval 2.9 to 9.6
|
—
|
—
|
3.9 Fold Rise
Interval 2.2 to 7.1
|
|
HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: B2
|
—
|
—
|
—
|
—
|
—
|
1.4 Fold Rise
Interval 0.9 to 2.2
|
2.1 Fold Rise
Interval 1.1 to 4.1
|
2.1 Fold Rise
Interval 1.2 to 3.9
|
4.0 Fold Rise
Interval 1.8 to 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination 2 and at 1, 4, and 8 Weeks After last VaccinationPopulation: EIP included all eligible participants who received vaccination; had blood drawn for assay testing within the specified time frame (26-35 days) after last 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. Here,'Overall Number of Participants Analyzed' signifies 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 \>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=98 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=108 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=105 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=24 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: B1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
40.6 Percentage of participants
Interval 30.7 to 51.1
|
45.3 Percentage of participants
Interval 35.6 to 55.2
|
39.0 Percentage of participants
Interval 29.7 to 49.1
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
22.3 Percentage of participants
Interval 14.4 to 32.1
|
31.4 Percentage of participants
Interval 22.7 to 41.2
|
21.9 Percentage of participants
Interval 14.4 to 31.0
|
25.0 Percentage of participants
Interval 9.8 to 46.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
3.1 Percentage of participants
Interval 0.6 to 8.9
|
7.5 Percentage of participants
Interval 3.3 to 14.2
|
30.5 Percentage of participants
Interval 21.9 to 40.2
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
55.1 Percentage of participants
Interval 44.7 to 65.2
|
62.6 Percentage of participants
Interval 52.7 to 71.8
|
49.5 Percentage of participants
Interval 39.6 to 59.5
|
75.0 Percentage of participants
Interval 53.3 to 90.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
11.3 Percentage of participants
Interval 5.8 to 19.4
|
20.4 Percentage of participants
Interval 13.2 to 29.2
|
32.4 Percentage of participants
Interval 23.6 to 42.2
|
87.5 Percentage of participants
Interval 67.6 to 97.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
40.2 Percentage of participants
Interval 30.4 to 50.7
|
58.1 Percentage of participants
Interval 48.1 to 67.7
|
29.5 Percentage of participants
Interval 21.0 to 39.2
|
37.5 Percentage of participants
Interval 18.8 to 59.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
59.2 Percentage of participants
Interval 48.8 to 69.0
|
58.5 Percentage of participants
Interval 48.5 to 68.0
|
37.1 Percentage of participants
Interval 27.9 to 47.1
|
83.3 Percentage of participants
Interval 62.6 to 95.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
41.1 Percentage of participants
Interval 31.1 to 51.6
|
50.5 Percentage of participants
Interval 40.5 to 60.4
|
17.1 Percentage of participants
Interval 10.5 to 25.7
|
75.0 Percentage of participants
Interval 53.3 to 90.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
4.1 Percentage of participants
Interval 1.1 to 10.2
|
7.5 Percentage of participants
Interval 3.3 to 14.2
|
18.1 Percentage of participants
Interval 11.3 to 26.8
|
33.3 Percentage of participants
Interval 15.6 to 55.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.0 Percentage of participants
Interval 0.0 to 5.6
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
21.9 Percentage of participants
Interval 14.4 to 31.0
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
6.3 Percentage of participants
Interval 2.3 to 13.1
|
12.0 Percentage of participants
Interval 6.6 to 19.7
|
33.7 Percentage of participants
Interval 24.7 to 43.6
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: A1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
75.0 Percentage of participants
Interval 53.3 to 90.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
8.4 Percentage of participants
Interval 3.7 to 15.9
|
12.1 Percentage of participants
Interval 6.6 to 19.9
|
29.5 Percentage of participants
Interval 21.0 to 39.2
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination 2 (2-visit arms only), 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1 visit and vaccination 2 for 2 visit)Population: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for 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\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest.Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=12 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=16 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: A1
|
—
|
—
|
—
|
—
|
—
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: A2
|
—
|
—
|
—
|
—
|
—
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: B1
|
—
|
—
|
—
|
—
|
—
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: B2
|
—
|
—
|
—
|
—
|
—
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: A1
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
—
|
—
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: B1
|
—
|
—
|
—
|
—
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 23.2
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: A2
|
—
|
—
|
—
|
—
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
—
|
—
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after last vaccination: B2
|
—
|
—
|
—
|
—
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
0.0 Percentage of participants
Interval 0.0 to 21.8
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
—
|
—
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
—
|
—
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
73.3 Percentage of participants
Interval 44.9 to 92.2
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
—
|
—
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
—
|
—
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
72.7 Percentage of participants
Interval 39.0 to 94.0
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
73.3 Percentage of participants
Interval 44.9 to 92.2
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
84.6 Percentage of participants
Interval 54.6 to 98.1
|
—
|
—
|
57.1 Percentage of participants
Interval 28.9 to 82.3
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
—
|
—
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
—
|
—
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
9.1 Percentage of participants
Interval 0.2 to 41.3
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
0.0 Percentage of participants
Interval 0.0 to 24.7
|
—
|
—
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
SECONDARY outcome
Timeframe: Before vaccination 1 and 2 and at 1, 4 and 8 weeks after last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last 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=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
Proportion of participants achieving HAI titers \>= 1:40 for each strain before vaccination and at 1, 4 and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=116 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=25 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: B2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.0 Percentage of participants
Interval 6.8 to 40.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 Week after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
82.0 Percentage of participants
Interval 73.1 to 89.0
|
84.1 Percentage of participants
Interval 75.8 to 90.5
|
82.9 Percentage of participants
Interval 74.3 to 89.5
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 Week after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
53.0 Percentage of participants
Interval 42.8 to 63.1
|
54.2 Percentage of participants
Interval 44.3 to 63.9
|
72.4 Percentage of participants
Interval 62.8 to 80.7
|
44.0 Percentage of participants
Interval 24.4 to 65.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
54.3 Percentage of participants
Interval 44.3 to 64.0
|
60.9 Percentage of participants
Interval 51.1 to 70.1
|
77.8 Percentage of participants
Interval 68.8 to 85.2
|
52.0 Percentage of participants
Interval 31.3 to 72.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
94.3 Percentage of participants
Interval 88.0 to 97.9
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
88.9 Percentage of participants
Interval 81.4 to 94.1
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: A2:
|
—
|
—
|
—
|
—
|
—
|
94.2 Percentage of participants
Interval 87.8 to 97.8
|
91.6 Percentage of participants
Interval 84.6 to 96.1
|
58.3 Percentage of participants
Interval 48.5 to 67.7
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: B2:
|
—
|
—
|
—
|
—
|
—
|
29.5 Percentage of participants
Interval 21.0 to 39.2
|
29.4 Percentage of participants
Interval 21.0 to 38.8
|
50.9 Percentage of participants
Interval 41.1 to 60.7
|
24.0 Percentage of participants
Interval 9.4 to 45.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 1: A1
|
—
|
—
|
—
|
—
|
—
|
48.0 Percentage of participants
Interval 37.8 to 58.3
|
51.4 Percentage of participants
Interval 41.5 to 61.2
|
47.6 Percentage of participants
Interval 37.8 to 57.6
|
33.3 Percentage of participants
Interval 15.6 to 55.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 1: A2
|
—
|
—
|
—
|
—
|
—
|
67.0 Percentage of participants
Interval 56.7 to 76.2
|
52.8 Percentage of participants
Interval 42.9 to 62.5
|
54.3 Percentage of participants
Interval 44.3 to 64.0
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 1: B1
|
—
|
—
|
—
|
—
|
—
|
30.9 Percentage of participants
Interval 21.9 to 41.1
|
33.3 Percentage of participants
Interval 24.6 to 43.1
|
33.3 Percentage of participants
Interval 24.4 to 43.2
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 1: B2
|
—
|
—
|
—
|
—
|
—
|
23.5 Percentage of participants
Interval 15.5 to 33.1
|
34.3 Percentage of participants
Interval 25.4 to 44.0
|
23.8 Percentage of participants
Interval 16.0 to 33.1
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: A1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: A2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2: B1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28.0 Percentage of participants
Interval 12.1 to 49.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 Week after last vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
86.9 Percentage of participants
Interval 78.6 to 92.8
|
84.8 Percentage of participants
Interval 76.4 to 91.0
|
84.8 Percentage of participants
Interval 76.4 to 91.0
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 Week after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
38.0 Percentage of participants
Interval 28.5 to 48.3
|
40.2 Percentage of participants
Interval 30.8 to 50.1
|
63.8 Percentage of participants
Interval 53.9 to 73.0
|
28.0 Percentage of participants
Interval 12.1 to 49.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
88.6 Percentage of participants
Interval 80.9 to 94.0
|
92.7 Percentage of participants
Interval 86.2 to 96.8
|
86.1 Percentage of participants
Interval 78.1 to 92.0
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
39.8 Percentage of participants
Interval 30.3 to 49.9
|
50.0 Percentage of participants
Interval 40.3 to 59.7
|
66.4 Percentage of participants
Interval 56.6 to 75.2
|
28.0 Percentage of participants
Interval 12.1 to 49.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: A1:
|
—
|
—
|
—
|
—
|
—
|
89.5 Percentage of participants
Interval 82.0 to 94.7
|
88.1 Percentage of participants
Interval 80.5 to 93.5
|
75.0 Percentage of participants
Interval 65.7 to 82.8
|
92.0 Percentage of participants
Interval 74.0 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination: B1:
|
—
|
—
|
—
|
—
|
—
|
36.2 Percentage of participants
Interval 27.0 to 46.1
|
41.3 Percentage of participants
Interval 31.9 to 51.1
|
46.3 Percentage of participants
Interval 36.7 to 56.2
|
44.0 Percentage of participants
Interval 24.4 to 65.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination 1 and 2 (for 2-visit only), and 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1-visit arms and vaccination 2 for 2-visit arms)Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last 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=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
Percentage of participants achieving HAI titers \>= 1:40 for each strain before vaccinations 1 and 2 and at 1, 4 and 8 weeks after last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=12 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=16 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 1: A1
|
—
|
—
|
—
|
—
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
63.6 Percentage of participants
Interval 63.6 to 89.1
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
69.2 Percentage of participants
Interval 38.6 to 90.9
|
—
|
—
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 1: A2
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
72.7 Percentage of participants
Interval 39.0 to 94.0
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
—
|
—
|
40.0 Percentage of participants
Interval 16.3 to 67.7
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 1: B1
|
—
|
—
|
—
|
—
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
—
|
—
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 1: B2
|
—
|
—
|
—
|
—
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
—
|
—
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: A1
|
—
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: A2
|
—
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: B2
|
—
|
—
|
—
|
—
|
—
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after the last vaccination: B1
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
80.0 Percentage of participants
Interval 44.4 to 97.5
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
26.7 Percentage of participants
Interval 7.8 to 55.1
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
—
|
—
|
60.0 Percentage of participants
Interval 32.3 to 83.7
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after the last vaccination: A1
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
85.7 Percentage of participants
Interval 57.2 to 98.2
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
—
|
—
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after the last vaccination: A2
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
85.7 Percentage of participants
Interval 57.2 to 98.2
|
100.0 Percentage of participants
Interval 75.3 to 100.0
|
—
|
—
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after the last vaccination: B1
|
—
|
—
|
—
|
—
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
53.3 Percentage of participants
Interval 26.6 to 78.7
|
71.4 Percentage of participants
Interval 41.9 to 91.6
|
46.2 Percentage of participants
Interval 19.2 to 74.9
|
—
|
—
|
78.6 Percentage of participants
Interval 49.2 to 95.3
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after the last vaccination: B2
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
—
|
—
|
42.9 Percentage of participants
Interval 17.7 to 71.1
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after the last vaccination: A1:
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
64.3 Percentage of participants
Interval 35.1 to 87.2
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
—
|
—
|
92.9 Percentage of participants
Interval 66.1 to 99.8
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after the last vaccination: A2:
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
57.1 Percentage of participants
Interval 28.9 to 82.3
|
92.3 Percentage of participants
Interval 64.0 to 99.8
|
—
|
—
|
100.0 Percentage of participants
Interval 76.8 to 100.0
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after the last vaccination: B1:
|
—
|
—
|
—
|
—
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
70.0 Percentage of participants
Interval 34.8 to 93.3
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
46.2 Percentage of participants
Interval 19.2 to 74.9
|
—
|
—
|
78.6 Percentage of participants
Interval 49.2 to 95.3
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after the last vaccination: B2:
|
—
|
—
|
—
|
—
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
63.6 Percentage of participants
Interval 30.8 to 89.1
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
28.6 Percentage of participants
Interval 8.4 to 58.1
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
—
|
—
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after the last vaccination: A1
|
—
|
—
|
—
|
—
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
78.6 Percentage of participants
Interval 49.2 to 95.3
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
—
|
—
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after the last vaccination: A2
|
—
|
—
|
—
|
—
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
100.0 Percentage of participants
Interval 69.2 to 100.0
|
90.0 Percentage of participants
Interval 55.5 to 99.7
|
100.0 Percentage of participants
Interval 71.5 to 100.0
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
100.0 Percentage of participants
Interval 78.2 to 100.0
|
100.0 Percentage of participants
Interval 76.8 to 100.0
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
—
|
—
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after the last vaccination: B2
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
—
|
—
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2: B1
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
91.7 Percentage of participants
Interval 61.5 to 99.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last 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=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
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\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=116 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=24 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination
|
—
|
—
|
—
|
—
|
—
|
1.1 Percentage of participants
Interval 0.0 to 5.8
|
0.0 Percentage of participants
Interval 0.0 to 3.5
|
4.8 Percentage of participants
Interval 1.6 to 10.8
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of participants
Interval 0.0 to 3.9
|
2.9 Percentage of participants
Interval 0.6 to 8.2
|
10.5 Percentage of participants
Interval 5.3 to 18.0
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.2 Percentage of participants
Interval 0.1 to 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination
|
—
|
—
|
—
|
—
|
—
|
3.2 Percentage of participants
Interval 0.7 to 9.0
|
7.7 Percentage of participants
Interval 3.4 to 14.6
|
13.5 Percentage of participants
Interval 7.6 to 21.6
|
12.5 Percentage of participants
Interval 2.7 to 32.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last 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=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
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\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=12 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=16 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=14 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2
|
—
|
—
|
—
|
—
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 3.8
|
10.0 Percentage of Participants
Interval 0.3 to 44.5
|
18.2 Percentage of Participants
Interval 2.3 to 51.8
|
41.7 Percentage of Participants
Interval 15.2 to 72.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 week after the last vaccination
|
—
|
—
|
—
|
—
|
16.7 Percentage of Participants
Interval 2.1 to 48.4
|
10.0 Percentage of Participants
Interval 0.3 to 44.5
|
10.0 Percentage of Participants
Interval 0.3 to 44.5
|
18.2 Percentage of Participants
Interval 2.3 to 51.8
|
33.3 Percentage of Participants
Interval 9.9 to 65.1
|
0.0 Percentage of Participants
Interval 0.0 to 26.5
|
16.7 Percentage of Participants
Interval 2.1 to 48.4
|
0.0 Percentage of Participants
Interval 0.0 to 21.8
|
14.3 Percentage of Participants
Interval 1.8 to 42.8
|
0.0 Percentage of Participants
Interval 0.0 to 28.5
|
—
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 23.2
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 weeks after the last vaccination
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
Interval 5.5 to 57.2
|
20.0 Percentage of Participants
Interval 2.5 to 55.6
|
0.0 Percentage of Participants
Interval 0.0 to 30.8
|
9.1 Percentage of Participants
Interval 0.2 to 41.3
|
16.7 Percentage of Participants
Interval 2.1 to 48.4
|
25.0 Percentage of Participants
Interval 5.5 to 57.2
|
16.7 Percentage of Participants
Interval 2.1 to 48.4
|
20.0 Percentage of Participants
Interval 4.3 to 48.1
|
7.1 Percentage of Participants
Interval 0.2 to 33.9
|
0.0 Percentage of Participants
Interval 0.0 to 24.7
|
—
|
—
|
0.0 Percentage of Participants
Interval 0.0 to 23.2
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 weeks after the last vaccination
|
—
|
—
|
—
|
—
|
9.1 Percentage of Participants
Interval 0.2 to 41.3
|
10.0 Percentage of Participants
Interval 0.3 to 44.5
|
0.0 Percentage of Participants
Interval 0.0 to 30.8
|
0.0 Percentage of Participants
Interval 0.0 to 30.8
|
25.0 Percentage of Participants
Interval 5.5 to 57.2
|
9.1 Percentage of Participants
Interval 0.2 to 41.3
|
18.2 Percentage of Participants
Interval 2.3 to 51.8
|
0.0 Percentage of Participants
Interval 0.0 to 21.8
|
0.0 Percentage of Participants
Interval 0.0 to 23.2
|
0.0 Percentage of Participants
Interval 0.0 to 24.7
|
—
|
—
|
7.7 Percentage of Participants
Interval 0.2 to 36.0
|
SECONDARY outcome
Timeframe: Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last 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=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
Percentage of participants with HAI titers \>=1:40 for all strains before vaccinations 1 and 2 and 1, 4, and 8 weeks after the last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=116 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=117 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=115 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=25 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
4 weeks after last vaccination
|
—
|
—
|
—
|
—
|
—
|
27.2 Percentage of participants
Interval 18.9 to 36.8
|
36.4 Percentage of participants
Interval 27.4 to 46.3
|
52.3 Percentage of participants
Interval 42.5 to 62.1
|
20.0 Percentage of participants
Interval 6.8 to 40.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
8 weeks after last vaccination
|
—
|
—
|
—
|
—
|
—
|
13.6 Percentage of participants
Interval 7.6 to 21.8
|
13.1 Percentage of participants
Interval 7.3 to 21.0
|
25.9 Percentage of participants
Interval 18.0 to 35.2
|
12.0 Percentage of participants
Interval 2.5 to 13.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 1
|
—
|
—
|
—
|
—
|
—
|
5.2 Percentage of participants
Interval 1.7 to 11.7
|
12.1 Percentage of participants
Interval 6.6 to 19.9
|
10.5 Percentage of participants
Interval 5.3 to 18.0
|
0.0 Percentage of participants
Interval 0.0 to 14.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
Prior to vaccination 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.0 Percentage of participants
Interval 2.5 to 31.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
1 week after last vaccination
|
—
|
—
|
—
|
—
|
—
|
24.2 Percentage of participants
Interval 16.2 to 33.9
|
26.7 Percentage of participants
Interval 18.5 to 36.2
|
40.0 Percentage of participants
Interval 30.6 to 50.0
|
16.0 Percentage of participants
Interval 4.5 to 36.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)Population: EIP included all eligible participants who received vaccination;had blood drawn for assay testing within the specified time frame(26-35 days) after last 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=participants evaluable for specified rows. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row.
Percentage of participants with HAI titers \>=1:40 for all strains before vaccinations 1 and 2 and 1, 4, and 8 weeks after the last vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=12 Participants
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=14 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=16 Participants
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=16 Participants
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 Participants
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=13 Participants
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=14 Participants
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 1
|
—
|
—
|
—
|
—
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
10.0 Percentage of participants
Interval 0.3 to 44.5
|
18.2 Percentage of participants
Interval 2.3 to 51.8
|
25.0 Percentage of participants
Interval 5.5 to 57.2
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
16.7 Percentage of participants
Interval 2.1 to 48.4
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
—
|
—
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
4 Weeks after the last vaccination
|
—
|
—
|
—
|
—
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
36.4 Percentage of participants
Interval 10.9 to 69.2
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
21.4 Percentage of participants
Interval 4.7 to 50.8
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
—
|
—
|
35.7 Percentage of participants
Interval 12.8 to 64.9
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
8 Weeks after the last vaccination
|
—
|
—
|
—
|
—
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
45.5 Percentage of participants
Interval 16.7 to 76.6
|
20.0 Percentage of participants
Interval 4.3 to 48.1
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
15.4 Percentage of participants
Interval 1.9 to 45.4
|
—
|
—
|
30.8 Percentage of participants
Interval 9.1 to 61.4
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
Prior to Vaccination 2
|
—
|
—
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 0.0
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
50.0 Percentage of participants
Interval 18.7 to 81.3
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
0 Percentage of participants
Interval 0.0 to 0.0
|
—
|
—
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
1 Week after the last vaccination
|
—
|
—
|
—
|
—
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
60.0 Percentage of participants
Interval 26.2 to 87.8
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
27.3 Percentage of participants
Interval 6.0 to 61.0
|
—
|
—
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
SECONDARY outcome
Timeframe: Before vaccination and 1, 4, and 8 Weeks After the VaccinationPopulation: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
HAI GMT before vaccination and at 1, 4, and 8 weeks after vaccination was described in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=128 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=129 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
11.6 Titers
Interval 9.7 to 13.8
|
11.6 Titers
Interval 9.8 to 13.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
17.9 Titers
Interval 14.8 to 21.5
|
19.1 Titers
Interval 15.8 to 23.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
21.4 Titers
Interval 16.8 to 27.3
|
18.0 Titers
Interval 14.4 to 22.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
16.5 Titers
Interval 13.4 to 20.4
|
13.2 Titers
Interval 11.0 to 15.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
22.1 Titers
Interval 17.7 to 27.6
|
19.0 Titers
Interval 15.7 to 23.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 week after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
113.0 Titers
Interval 85.3 to 149.7
|
124.6 Titers
Interval 95.2 to 163.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 week after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
52.7 Titers
Interval 41.4 to 67.1
|
72.3 Titers
Interval 57.3 to 91.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 week after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
39.3 Titers
Interval 31.3 to 49.2
|
37.1 Titers
Interval 29.8 to 46.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 week after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
16.0 Titers
Interval 13.3 to 19.2
|
19.0 Titers
Interval 15.7 to 23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
317.3 Titers
Interval 251.8 to 399.8
|
273.6 Titers
Interval 215.9 to 346.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
140.9 Titers
Interval 118.1 to 168.2
|
148.2 Titers
Interval 123.9 to 177.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
58.9 Titers
Interval 48.8 to 71.1
|
48.2 Titers
Interval 39.6 to 58.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
19.8 Titers
Interval 16.4 to 23.8
|
23.3 Titers
Interval 19.1 to 28.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
228.9 Titers
Interval 183.2 to 285.9
|
221.2 Titers
Interval 176.2 to 277.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
80.0 Titers
Interval 64.3 to 99.5
|
92.6 Titers
Interval 76.4 to 112.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
39.0 Titers
Interval 32.0 to 47.6
|
34.8 Titers
Interval 27.8 to 43.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination to 1, 4, and 8 Weeks After VaccinationPopulation: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for 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 prevaccination assay results were lower than the LLOQ and the postvaccination results were greater than or equal to the LLOQ, the pre vaccination assay results were set to LLOQ for the GMFR calculation.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=113 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=110 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
1.7 Fold Rise
Interval 1.5 to 1.9
|
1.7 Fold Rise
Interval 1.4 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.3 Fold Rise
Interval 1.2 to 1.4
|
1.4 Fold Rise
Interval 1.3 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
4.5 Fold Rise
Interval 3.6 to 5.6
|
5.7 Fold Rise
Interval 4.5 to 7.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
2.7 Fold Rise
Interval 2.3 to 3.3
|
4.4 Fold Rise
Interval 3.6 to 5.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
1.7 Fold Rise
Interval 1.5 to 1.9
|
1.8 Fold Rise
Interval 1.6 to 2.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.2 Fold Rise
Interval 1.1 to 1.3
|
1.4 Fold Rise
Interval 1.3 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
12.3 Fold Rise
Interval 9.6 to 15.7
|
12.2 Fold Rise
Interval 9.5 to 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
6.8 Fold Rise
Interval 5.7 to 8.2
|
8.7 Fold Rise
Interval 7.1 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
2.4 Fold Rise
Interval 2.1 to 2.8
|
2.2 Fold Rise
Interval 1.9 to 2.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
1.4 Fold Rise
Interval 1.3 to 1.6
|
1.7 Fold Rise
Interval 1.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
8.9 Fold Rise
Interval 7.1 to 11.3
|
9.9 Fold Rise
Interval 8.0 to 12.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
3.9 Fold Rise
Interval 3.2 to 4.9
|
5.5 Fold Rise
Interval 4.6 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 4, and 8 Weeks After VaccinationPopulation: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for 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\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
83.0 Percentage of participants
Interval 74.8 to 89.5
|
88.9 Percentage of participants
Interval 81.4 to 94.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
11.7 Percentage of participants
Interval 6.4 to 19.2
|
21.8 Percentage of participants
Interval 14.5 to 30.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
9.2 Percentage of participants
Interval 4.5 to 16.2
|
10.3 Percentage of participants
Interval 5.2 to 17.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
57.1 Percentage of participants
Interval 47.4 to 66.5
|
65.5 Percentage of participants
Interval 55.8 to 74.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
51.8 Percentage of participants
Interval 42.1 to 61.3
|
58.2 Percentage of participants
Interval 48.4 to 67.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
23.4 Percentage of participants
Interval 15.9 to 32.4
|
26.6 Percentage of participants
Interval 18.6 to 35.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
5.4 Percentage of participants
Interval 2.0 to 11.4
|
12.7 Percentage of participants
Interval 7.1 to 20.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
80.4 Percentage of participants
Interval 71.8 to 87.3
|
89.0 Percentage of participants
Interval 81.6 to 94.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
40.2 Percentage of participants
Interval 31.0 to 49.9
|
32.4 Percentage of participants
Interval 23.7 to 42.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
79.1 Percentage of participants
Interval 70.3 to 86.3
|
86.2 Percentage of participants
Interval 78.3 to 92.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
60.6 Percentage of participants
Interval 50.5 to 70.0
|
76.1 Percentage of participants
Interval 67.0 to 83.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
22.7 Percentage of participants
Interval 15.3 to 31.7
|
21.3 Percentage of participants
Interval 14.0 to 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination and 1, 4, and 8 Weeks After VaccinationPopulation: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
Percentage of participants with HAI titers \>=1:40 for each strain before vaccination and 1, 4, and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
61.6 Percentage of participants
Interval 51.9 to 70.6
|
53.6 Percentage of participants
Interval 43.9 to 63.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
94.6 Percentage of participants
Interval 88.6 to 98.0
|
95.4 Percentage of participants
Interval 89.6 to 98.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
28.2 Percentage of participants
Interval 20.0 to 37.6
|
37.4 Percentage of participants
Interval 28.2 to 47.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
39.3 Percentage of participants
Interval 30.2 to 49.0
|
35.5 Percentage of participants
Interval 26.6 to 45.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
34.8 Percentage of participants
Interval 26.1 to 44.4
|
24.5 Percentage of participants
Interval 16.8 to 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
35.7 Percentage of participants
Interval 26.9 to 45.3
|
37.6 Percentage of participants
Interval 28.5 to 47.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
17.9 Percentage of participants
Interval 11.3 to 26.2
|
17.3 Percentage of participants
Interval 10.7 to 25.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
82.3 Percentage of participants
Interval 74.0 to 88.8
|
81.8 Percentage of participants
Interval 73.3 to 88.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
75.2 Percentage of participants
Interval 66.2 to 82.9
|
79.1 Percentage of participants
Interval 70.3 to 86.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
25.9 Percentage of participants
Interval 18.1 to 35.0
|
35.5 Percentage of participants
Interval 26.6 to 45.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: A1
|
—
|
—
|
—
|
—
|
—
|
94.7 Percentage of participants
Interval 88.8 to 98.0
|
96.3 Percentage of participants
Interval 90.8 to 99.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
98.2 Percentage of participants
Interval 93.8 to 99.8
|
95.4 Percentage of participants
Interval 89.6 to 98.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
77.9 Percentage of participants
Interval 69.1 to 85.1
|
63.9 Percentage of participants
Interval 54.1 to 72.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination: B2
|
—
|
—
|
—
|
—
|
—
|
33.9 Percentage of participants
Interval 25.3 to 43.5
|
47.3 Percentage of participants
Interval 37.7 to 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: A2
|
—
|
—
|
—
|
—
|
—
|
86.7 Percentage of participants
Interval 78.6 to 92.5
|
90.8 Percentage of participants
Interval 83.8 to 95.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination: B1
|
—
|
—
|
—
|
—
|
—
|
61.3 Percentage of participants
Interval 51.5 to 70.4
|
53.2 Percentage of participants
Interval 43.4 to 62.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1, 4, and 8 Weeks After VaccinationPopulation: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for 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\>=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination
|
—
|
—
|
—
|
—
|
—
|
1.8 Percentage of participants
Interval 0.2 to 6.4
|
4.6 Percentage of participants
Interval 1.5 to 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination
|
—
|
—
|
—
|
—
|
—
|
7.2 Percentage of participants
Interval 3.2 to 13.7
|
9.3 Percentage of participants
Interval 4.6 to 16.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination
|
—
|
—
|
—
|
—
|
—
|
3.9 Percentage of participants
Interval 1.1 to 9.6
|
4.7 Percentage of participants
Interval 1.5 to 10.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination and 1, 4, and 8 Weeks After VaccinationPopulation: EIP=all eligible participants who received vaccination;had blood drawn for assay testing within specified time frame (26-35days)after Vaccination;had at least 1valid and determinate assay result at 4-week post-vaccination visit and had no major protocol deviations.All participants reported under'Overall Number of Participants Analyzed'contributed data to table;however,may not have evaluable data for every row and'Number Analyzed'signifies number of participants evaluable for specified rows.
Percentage of participants with HAI titers \>=1:40 for all strains before vaccination and 1, 4, and 8 weeks after vaccination is reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
SSA: bIRV AB (Dose Level Combination 2) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 1) + QIV
n=131 Participants
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=131 Participants
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: mIRV B - Licensed QIV
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
Prior to vaccination
|
—
|
—
|
—
|
—
|
—
|
6.3 Percentage of participants
Interval 2.5 to 12.5
|
1.8 Percentage of participants
Interval 0.2 to 6.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
1 Week after vaccination
|
—
|
—
|
—
|
—
|
—
|
15.3 Percentage of participants
Interval 9.2 to 23.4
|
20.9 Percentage of participants
Interval 13.7 to 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
4 Weeks after vaccination
|
—
|
—
|
—
|
—
|
—
|
26.8 Percentage of participants
Interval 18.9 to 36.0
|
32.7 Percentage of participants
Interval 24.0 to 42.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
8 Weeks after vaccination
|
—
|
—
|
—
|
—
|
—
|
14.4 Percentage of participants
Interval 8.3 to 22.7
|
22.4 Percentage of participants
Interval 14.9 to 31.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
SSA: mIRV A (Dose Level 1) + QIV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: mIRV A (Dose Level 2) + QIV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: mIRV A (Dose Level 3) + QIV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SSA: mIRV A (Dose Level 4) + QIV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: mIRV A - Licensed QIV
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SSA: mIRV B (Dose Level 1) + QIV
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: mIRV B (Dose Level 2) + QIV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SSA: mIRV B (Dose Level 3) + QIV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: mIRV B (Dose Level 4) + QIV
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SSA: mIRV B - Licensed QIV
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
SSA: bIRV AB (Dose Level Combination 1) + QIV
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: bIRV AB (Dose Level Combination 2) + QIV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSA: bIRV AB (Dose Level Combination 3) + QIV
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SSA: bIRV AB (Dose Level Combination 4) + QIV
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SSA: bIRV AB-Licensed QIV
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SSA: qIRV (Dose Level 1) + QIV
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
SSA: qIRV - Licensed QIV
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment
Serious events: 2 serious events
Other events: 92 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
Serious events: 1 serious events
Other events: 71 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
SSB: 1 Dose of QIV, 1 Visit Schedule, Expanded Enrollment
Serious events: 0 serious events
Other events: 52 other events
Deaths: 0 deaths
SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule, Expanded Enrollment
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSA: mIRV A (Dose Level 1) + QIV
n=16 participants at risk
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 participants at risk
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 participants at risk
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 participants at risk
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 participants at risk
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 participants at risk
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 participants at risk
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 participants at risk
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 participants at risk
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 participants at risk
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 participants at risk
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment
n=14 participants at risk
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 2 administered 21 days apart as a part of initial enrollment.
|
SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received two doses of licensed QIV administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 1) as part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 2) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) as a part of initial enrollment.
|
SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as part of initial enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment
n=131 participants at risk
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment
n=131 participants at risk
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 2 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
n=116 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
n=117 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) at Day 1 as part of expanded enrollment.
|
SSB: 1 Dose of QIV, 1 Visit Schedule, Expanded Enrollment
n=115 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as a part of expanded enrollment.
|
SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
n=14 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of bIRV AA + bIRV BB both dose level combination 1 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, dose combination 2 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 3 administered at day 1 as a part of initial enrollment.
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule, Expanded Enrollment
n=117 participants at risk
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of expanded enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.76%
1/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.76%
1/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Sepsis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.76%
1/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.76%
1/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.86%
1/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
Other adverse events
| Measure |
SSA: mIRV A (Dose Level 1) + QIV
n=16 participants at risk
Participants received a single injection of monovalent influenza modified ribonucleic acid, (modRNA) vaccine (mIRV) encoding A strain at dose level 1, intramuscularly into the deltoid muscle at Day 1 (vaccination 1). Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 2) + QIV
n=15 participants at risk
Participants received a single injection of mIRV encoding A strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 3) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding A strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A (Dose Level 4) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding A strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV A - Licensed QIV
n=15 participants at risk
Participants received a single injection of quadrivalent influenza vaccine (QIV), licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of either mIRV A or B at dose level 4 (vaccination 2).
|
SSA: mIRV B (Dose Level 1) + QIV
n=17 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 2) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 3) + QIV
n=15 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B (Dose Level 4) + QIV
n=14 participants at risk
Participants received a single injection of mIRV encoding B strain at dose level 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: mIRV B - Licensed QIV
n=15 participants at risk
Participants received a single injection of QIV, licensed, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 1) + QIV
n=14 participants at risk
Participants received a single injection of bivalent influenza modified RNA vaccine (bIRV) encoding A and B strains at dose level combination 1, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 2) + QIV
n=16 participants at risk
Participants received a single injection of bIRV encoding A and B strains at dose level combination 2, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 3) + QIV
n=15 participants at risk
Participants received a single injection of bIRV encoding A and B strains at dose level combination 3, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB (Dose Level Combination 4) + QIV
n=15 participants at risk
Participants received a single injection of bIRV encoding A and B strains at dose level combination 4, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: bIRV AB-Licensed QIV
n=15 participants at risk
Participants received a single injection of licensed quadrivalent influenza vaccine (QIV), intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSA: qIRV (Dose Level 1) + QIV
n=15 participants at risk
Participants received a single injection of quadrivalent influenza mod RNA vaccine (qIRV) - encoding 2A strains and 2B strains at a dose level 1 per strain, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, eligible participants received a single intramuscular dose of licensed QIV (vaccination 2).
|
SSA: qIRV - Licensed QIV
n=15 participants at risk
Participants received a single injection of licensed QIV, intramuscularly into the deltoid muscle at Day 1. Following unblinding at 8 weeks after vaccination 1, the licensed QIV control group received either a single intramuscular dose of injection of mIRV encoding A strain or B strain at dose level 4 (vaccination 2).
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule: Initial Enrollment
n=14 participants at risk
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 1), 2- Visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 1 administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV + bIRV AA (Dose Level Combination 2), 2- Visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV followed by a single intramuscular injection of bIRV encoding AA strains at dose level combination 2 administered 21 days apart as a part of initial enrollment.
|
SSB: 2 Doses of Licensed QIV, 2-visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received two doses of licensed QIV administered 21 days apart as a part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 1) as part of initial enrollment.
|
SSB: Licensed QIV +bIRV AA (Dose Level Combination 2), 1-visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV administered concurrently in the opposite arm with a single intramuscular injection of bIRV AA (dose level combination 2) as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) as a part of initial enrollment.
|
SSB: 1 Dose of Licensed QIV, 1 Visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as part of initial enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 18-64 Years: Expanded Enrollment
n=131 participants at risk
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 2), 1-visit Schedule, 18-64 Years : Expanded Enrollment
n=131 participants at risk
Participants aged 18 to 64 years received a single intramuscular injection of qIRV dose level 2 as a part of expanded enrollment.
|
SSB: qIRV (Dose Level 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
n=116 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 1 as a part of expanded enrollment
|
SSB: qIRV (Dose Level 2, Dose Combination 1), 1-visit Schedule, 65 to 85 Years: Expanded Enrollment
n=117 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, encoding 2A strains and 2B strains (dose combination 1) at Day 1 as part of expanded enrollment.
|
SSB: 1 Dose of QIV, 1 Visit Schedule, Expanded Enrollment
n=115 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of licensed QIV as a part of expanded enrollment.
|
SSB: bIRV AA + bIRV BB ( Both Dose Level Combination 1), 1-visit Schedule: Initial Enrollment
n=14 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of bIRV AA + bIRV BB both dose level combination 1 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 2, Dose Combination 2), 1-Visit Schedule: Initial Enrollment
n=16 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 2, dose combination 2 administered at day 1 as a part of initial enrollment.
|
SSB: qIRV (Dose Level 3), 1-Visit Schedule: Initial Enrollment
n=15 participants at risk
Participants aged 65 to 85 years received a single intramuscular injection of qIRV dose level 3 administered at day 1 as a part of initial enrollment.
|
SSB: 2 Doses qIRV (Dose Level 1), 2 Visit Schedule, Expanded Enrollment
n=117 participants at risk
Participants aged 65 to 85 years received intramuscular injections with 2 doses qIRV at dose Level 1 administered 21 days apart as a part of expanded enrollment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.86%
1/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.85%
1/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
1.7%
2/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
1.7%
2/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
18.8%
3/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
11.8%
2/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
18.8%
3/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
28.6%
4/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
31.2%
5/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
27.5%
36/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
32.1%
42/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
16.4%
19/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
25/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.8%
9/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
25/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord dysfunction
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Injection site pruritus
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Medical device site reaction
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.85%
1/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Eye disorders
Cataract
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Cardiac disorders
Ventricular extrasystoles
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.2%
16/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.9%
9/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
4.3%
5/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
4.3%
5/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.2%
6/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
2.3%
3/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
1.5%
2/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
2.6%
3/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Chest discomfort
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Chills
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Fatigue
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Injection site erythema (REDNESS)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
9.9%
13/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.2%
16/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
3.4%
4/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.7%
9/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
4.3%
5/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.7%
4/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.0%
14/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Injection site pain (PAIN)
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
50.0%
7/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
64.3%
9/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
53.3%
8/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.3%
6/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
28.6%
4/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
46.7%
7/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.7%
5/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
46.7%
7/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
42.9%
6/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
31.2%
5/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
60.0%
9/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
46.7%
7/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
40.0%
6/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
86.7%
13/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
66.7%
10/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
57.1%
8/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
53.3%
8/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
37.5%
6/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
37.5%
6/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
37.5%
6/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
60.0%
9/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
50.0%
8/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
60.3%
79/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
62.6%
82/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
44.0%
51/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
58.1%
68/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
27.8%
32/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
28.6%
4/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
37.5%
6/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
40.0%
6/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
58.1%
68/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Injection site swelling (SWELLING)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
9.9%
13/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
16.8%
22/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
10.3%
12/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
10.3%
12/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.2%
6/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
18.8%
3/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
15.4%
18/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Pyrexia (FEVER)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
3.8%
5/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
8.4%
11/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
3.4%
4/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.0%
7/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
2.6%
3/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.1%
6/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Chest pain
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Investigations
Body temperature increased
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.7%
4/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
18.8%
3/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
18.3%
24/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
17.6%
23/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.9%
15/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
17.1%
20/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.87%
1/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
10.3%
12/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Nervous system disorders
Headache (HEADACHE)
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
17.6%
3/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
28.6%
4/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.7%
4/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.7%
5/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
31.2%
5/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
38.2%
50/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.9%
47/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.7%
24/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
27.4%
32/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
10.4%
12/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.5%
31/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Vascular disorders
Haematoma
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
4.3%
5/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
4.3%
5/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.2%
6/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.8%
8/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Chills (CHILLS)
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
5.9%
1/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.2%
1/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.7%
4/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.7%
5/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
12.5%
2/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
19.1%
25/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.6%
27/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.9%
8/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
17.9%
21/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
4.3%
5/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
19.7%
23/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
General disorders
Fatigue (FATIGUE)
|
31.2%
5/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
13.3%
2/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.7%
5/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
17.6%
3/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
14.3%
2/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.0%
3/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.7%
5/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
40.0%
6/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.7%
5/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
40.0%
6/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
46.7%
7/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.7%
4/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
40.0%
6/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
53.3%
8/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
50.0%
7/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
46.7%
7/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
31.2%
5/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
31.2%
5/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
33.3%
5/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
43.5%
57/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
41.2%
54/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
32.8%
38/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
41.9%
49/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
20.9%
24/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
21.4%
3/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
25.0%
4/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
26.7%
4/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
35.9%
42/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
7.1%
1/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/17 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
6.7%
1/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/131 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/116 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/115 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/14 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/16 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/15 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
0.00%
0/117 • Local reactions/systemic events(Systematic assessment): from Day 1 to Day 7 after vaccination 1 and/or 2;Non-systematic assessment: SAEs: from vaccination 1 up to 6 months after last vaccination: other AEs: from vaccination 1 up to 4 weeks after last vaccination (After vaccination 2 for SSA arms and SSB 2-visit schedule arms and after vaccination 1 for SSB 1-visit schedule arms).
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both AE and non-SAE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER