Trial Outcomes & Findings for Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern (NCT NCT05168813)
NCT ID: NCT05168813
Last Updated: 2025-11-26
Results Overview
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. Because additional NAAT testing was performed at Month 1 for AG1 but not AG2-1, NAAT results at Month 1 were not considered. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
14237 participants
Primary outcome timeframe
1 day after Month 1 dose until Month 6 dose
Results posted on
2025-11-26
Participant Flow
The study was conducted in two parts: Part A (open-label) and Part B (blinded).
In Part A, participants were enrolled into 4 study groups defined by baseline HIV and SARS-CoV-2 anti-S status. All ppts received mRNA-1273 at Month 0. Study groups 1 and 3 also received mRNA-1273 at Month 1. 236 ppts were excluded due to major data issues. In Part B, ppts who received Month 6 vaccination under protocol v6+ were randomized to mRNA-1273 or mRNA-1273.222. Ppts who received M6 vaccination before protocol v6 were not randomized because mRNA-1273.222 was unavailable.
Participant milestones
| Measure |
Part A (Open-label): Study Group 1
Baseline HIV positive, baseline SARS-CoV-2 anti-S negative
|
Part A (Open Label): Study Group 2
Baseline HIV positive, baseline SARS-CoV-2 anti-S positive
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part A (Open-label): Study Group 4
Baseline HIV negative, baseline SARS-CoV-2 anti-S positive
|
Part B (Blinded): mRNA-1273 at Month 6
Received monovalent booster at Month 6
|
Part B (Blinded): mRNA-1273.222 at Month 6
Received bivalent booster at Month 6
|
|---|---|---|---|---|---|---|
|
Part A (Open-label)
STARTED
|
3740
|
7941
|
648
|
1672
|
0
|
0
|
|
Part A (Open-label)
Full Analysis Set (FAS)
|
3740
|
7941
|
648
|
1672
|
0
|
0
|
|
Part A (Open-label)
Safety Set (SS)
|
558
|
692
|
99
|
142
|
0
|
0
|
|
Part A (Open-label)
Immunogenicity Set (IS)
|
68
|
80
|
67
|
78
|
0
|
0
|
|
Part A (Open-label)
Per-Protocol Set (PP)
|
3604
|
7832
|
617
|
1607
|
0
|
0
|
|
Part A (Open-label)
COMPLETED
|
3648
|
7819
|
624
|
1606
|
0
|
0
|
|
Part A (Open-label)
NOT COMPLETED
|
92
|
122
|
24
|
66
|
0
|
0
|
|
Part B (Blinded)
STARTED
|
0
|
0
|
0
|
0
|
11243
|
2012
|
|
Part B (Blinded)
Received Month 6 Vaccination Set (FM6)
|
0
|
0
|
0
|
0
|
11243
|
2012
|
|
Part B (Blinded)
Randomized Month 6 Set (RM6)
|
0
|
0
|
0
|
0
|
1976
|
2012
|
|
Part B (Blinded)
Safety Set (SS)
|
0
|
0
|
0
|
0
|
1323
|
89
|
|
Part B (Blinded)
Immunogenicity Set (IS)
|
0
|
0
|
0
|
0
|
252
|
26
|
|
Part B (Blinded)
Full Per-Protocol Set (FPP)
|
0
|
0
|
0
|
0
|
1960
|
2002
|
|
Part B (Blinded)
COMPLETED
|
0
|
0
|
0
|
0
|
2086
|
1676
|
|
Part B (Blinded)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
9157
|
336
|
Reasons for withdrawal
| Measure |
Part A (Open-label): Study Group 1
Baseline HIV positive, baseline SARS-CoV-2 anti-S negative
|
Part A (Open Label): Study Group 2
Baseline HIV positive, baseline SARS-CoV-2 anti-S positive
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part A (Open-label): Study Group 4
Baseline HIV negative, baseline SARS-CoV-2 anti-S positive
|
Part B (Blinded): mRNA-1273 at Month 6
Received monovalent booster at Month 6
|
Part B (Blinded): mRNA-1273.222 at Month 6
Received bivalent booster at Month 6
|
|---|---|---|---|---|---|---|
|
Part A (Open-label)
Other
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A (Open-label)
Lost to Follow-up
|
21
|
39
|
8
|
26
|
0
|
0
|
|
Part A (Open-label)
Withdrawal by Subject
|
35
|
30
|
14
|
17
|
0
|
0
|
|
Part A (Open-label)
Death
|
23
|
28
|
1
|
9
|
0
|
0
|
|
Part A (Open-label)
Physician Decision
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Part A (Open-label)
Participant Unable to Adhere to Visit Schedule
|
10
|
18
|
0
|
7
|
0
|
0
|
|
Part A (Open-label)
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part A (Open-label)
Study Terminated by Sponsor
|
3
|
4
|
1
|
5
|
0
|
0
|
|
Part B (Blinded)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
219
|
88
|
|
Part B (Blinded)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
91
|
55
|
|
Part B (Blinded)
Death
|
0
|
0
|
0
|
0
|
63
|
19
|
|
Part B (Blinded)
Physician Decision
|
0
|
0
|
0
|
0
|
6
|
1
|
|
Part B (Blinded)
Participant Unable to Adhere to Visit Schedule
|
0
|
0
|
0
|
0
|
54
|
21
|
|
Part B (Blinded)
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part B (Blinded)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
8682
|
125
|
|
Part B (Blinded)
Other
|
0
|
0
|
0
|
0
|
41
|
27
|
Baseline Characteristics
Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern
Baseline characteristics by cohort
| Measure |
Part A (Open-label): Study Group 1, Analysis Group 1 (AG1)
n=2476 Participants
Participants in Study Group 1 who are baseline HIV positive and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 1, Analysis Group 2-2 (AG2-2)
n=1264 Participants
Participants in Study Group 1 who are baseline HIV positive and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 2, Analysis Group 2-1 (AG2-1)
n=7941 Participants
Participants in Study Group 2 who are baseline HIV positive and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=391 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
n=257 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
n=1672 Participants
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Total
n=14001 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39 years
n=492 Participants
|
40 years
n=492 Participants
|
39 years
n=984 Participants
|
34 years
n=3 Participants
|
39 years
n=8 Participants
|
34 years
n=3 Participants
|
39 years
n=5 Participants
|
|
Age, Customized
<=40 years
|
1388 Participants
n=492 Participants
|
681 Participants
n=492 Participants
|
4484 Participants
n=984 Participants
|
260 Participants
n=3 Participants
|
136 Participants
n=8 Participants
|
1099 Participants
n=3 Participants
|
8048 Participants
n=5 Participants
|
|
Age, Customized
> years
|
1088 Participants
n=492 Participants
|
583 Participants
n=492 Participants
|
3457 Participants
n=984 Participants
|
131 Participants
n=3 Participants
|
121 Participants
n=8 Participants
|
573 Participants
n=3 Participants
|
5953 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1676 Participants
n=492 Participants
|
911 Participants
n=492 Participants
|
6407 Participants
n=984 Participants
|
100 Participants
n=3 Participants
|
108 Participants
n=8 Participants
|
909 Participants
n=3 Participants
|
10111 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
800 Participants
n=492 Participants
|
353 Participants
n=492 Participants
|
1534 Participants
n=984 Participants
|
291 Participants
n=3 Participants
|
149 Participants
n=8 Participants
|
763 Participants
n=3 Participants
|
3890 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2475 Participants
n=492 Participants
|
1264 Participants
n=492 Participants
|
7940 Participants
n=984 Participants
|
391 Participants
n=3 Participants
|
257 Participants
n=8 Participants
|
1672 Participants
n=3 Participants
|
13999 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2433 Participants
n=492 Participants
|
1248 Participants
n=492 Participants
|
7848 Participants
n=984 Participants
|
358 Participants
n=3 Participants
|
233 Participants
n=8 Participants
|
1574 Participants
n=3 Participants
|
13694 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
4 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
43 Participants
n=492 Participants
|
15 Participants
n=492 Participants
|
91 Participants
n=984 Participants
|
29 Participants
n=3 Participants
|
23 Participants
n=8 Participants
|
96 Participants
n=3 Participants
|
297 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Eswatini
|
53 Participants
n=492 Participants
|
19 Participants
n=492 Participants
|
130 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=3 Participants
|
209 Participants
n=5 Participants
|
|
Region of Enrollment
Malawi
|
188 Participants
n=492 Participants
|
44 Participants
n=492 Participants
|
408 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
642 Participants
n=5 Participants
|
|
Region of Enrollment
Botswana
|
22 Participants
n=492 Participants
|
20 Participants
n=492 Participants
|
30 Participants
n=984 Participants
|
13 Participants
n=3 Participants
|
7 Participants
n=8 Participants
|
27 Participants
n=3 Participants
|
119 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
1530 Participants
n=492 Participants
|
808 Participants
n=492 Participants
|
5438 Participants
n=984 Participants
|
337 Participants
n=3 Participants
|
212 Participants
n=8 Participants
|
1463 Participants
n=3 Participants
|
9788 Participants
n=5 Participants
|
|
Region of Enrollment
Uganda
|
191 Participants
n=492 Participants
|
93 Participants
n=492 Participants
|
796 Participants
n=984 Participants
|
17 Participants
n=3 Participants
|
16 Participants
n=8 Participants
|
71 Participants
n=3 Participants
|
1184 Participants
n=5 Participants
|
|
Region of Enrollment
Zambia
|
257 Participants
n=492 Participants
|
179 Participants
n=492 Participants
|
584 Participants
n=984 Participants
|
7 Participants
n=3 Participants
|
14 Participants
n=8 Participants
|
74 Participants
n=3 Participants
|
1115 Participants
n=5 Participants
|
|
Region of Enrollment
Kenya
|
235 Participants
n=492 Participants
|
101 Participants
n=492 Participants
|
555 Participants
n=984 Participants
|
15 Participants
n=3 Participants
|
8 Participants
n=8 Participants
|
30 Participants
n=3 Participants
|
944 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day after Month 1 dose until Month 6 dosePopulation: FAS
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. Because additional NAAT testing was performed at Month 1 for AG1 but not AG2-1, NAAT results at Month 1 were not considered. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=2476 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=7941 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With a First Occurrence of CDC-defined COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Cohort Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1)
|
—
|
—
|
—
|
—
|
—
|
—
|
76 Participants
|
151 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 day after Month 0 dose until Month 6 dosePopulation: FAS
The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=2476 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=7941 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With a First Occurrence of COVE-defined COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Cohort Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1
|
—
|
—
|
—
|
—
|
—
|
—
|
30 Participants
|
40 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 day after Month 0 dose until Month 6 dosePopulation: FAS
The COVE-based severe COVID-19 endpoint is defined as the first occurrence of a confirmed case of COVE-based COVID-19, plus any of the following: 1. Clinical signs indicative of severe systemic illness, Respiratory Rate ≥ 30 per minute, Heart Rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 less than 300 mm Hg, OR 2. Respiratory failure or Acute Respiratory Distress Syndrome (ARDS), (defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure less than 90 mmHg, diastolic BP less than 60 mmHg or requiring vasopressors), OR 3. Significant acute renal, hepatic, or neurologic dysfunction, OR 4. Admission to an intensive care unit or death. The severe COVE criteria require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=2476 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=7941 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With a First Occurrence of COVE-based Severe COVID-19 Starting 1 Day After Month 0 Dose Until Month 6 Dose in FAS Between Analysis Group 1 (AG1) and Analysis Group 2-1 (AG2-1)
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Month 6 dose until end of follow up (up to 18 months)Population: Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort).
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=1976 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=2012 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Boost Groups
|
—
|
—
|
—
|
—
|
—
|
—
|
151 Participants
|
142 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Month 6 dose until end of follow up (up to 18 months)Population: Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort).
The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=1976 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=2012 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With a First Occurrence of COVE-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Boost Group
|
—
|
—
|
—
|
—
|
—
|
—
|
8 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Month 6 dose until end of follow up (up to 18 months)Population: Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort).
Statistical analyses were not performed because there are fewer than 7 severe COVE-based severe COVID-19 starting 14 days after Month 6 dose until end of follow up in RM6 cohort.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=1976 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=2012 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With a First Occurrence of COVE-based Severe COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Between Month 6 Monovalent and Bivalent Groups
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 7 days following Month 0 vaccination (all Study Groups) and up to 7 days following Month 1 vaccination (Study Groups 1 and 3)Population: Safety subset.
All solicited adverse events/reactogenicity symptoms are followed until resolution and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017. Local reacto symptoms collected are: erythema/redness, induration/swelling, lymphadenopathy, and pain/tenderness. Systemic reacto symptoms collected are: arthralgia, chills, fever, headache, malaise/fatigue, myalgia, and nausea.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=142 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=558 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=692 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=99 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
482 Participants
|
0 Participants
|
85 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
42 Participants
|
0 Participants
|
11 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
17 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
494 Participants
|
0 Participants
|
89 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
35 Participants
|
0 Participants
|
6 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
11 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
527 Participants
|
0 Participants
|
93 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
10 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
433 Participants
|
0 Participants
|
79 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
85 Participants
|
0 Participants
|
15 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
21 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
428 Participants
|
0 Participants
|
75 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
80 Participants
|
0 Participants
|
15 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
30 Participants
|
0 Participants
|
5 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
464 Participants
|
0 Participants
|
84 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
62 Participants
|
0 Participants
|
11 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
14 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
501 Participants
|
0 Participants
|
87 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
33 Participants
|
0 Participants
|
9 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 0 Vaccination · Grade 1
|
—
|
37 Participants
|
—
|
—
|
—
|
—
|
158 Participants
|
167 Participants
|
19 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 0 Vaccination · Grade 0
|
—
|
82 Participants
|
—
|
—
|
—
|
—
|
320 Participants
|
428 Participants
|
68 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 0 Vaccination · Grade 2
|
—
|
22 Participants
|
—
|
—
|
—
|
—
|
79 Participants
|
87 Participants
|
11 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 0 Vaccination · Grade 3
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
9 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
352 Participants
|
0 Participants
|
65 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
126 Participants
|
0 Participants
|
21 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
59 Participants
|
0 Participants
|
9 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
5 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 0 Vaccination · Grade 0
|
—
|
130 Participants
|
—
|
—
|
—
|
—
|
533 Participants
|
671 Participants
|
95 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 0 Vaccination · Grade 1
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
18 Participants
|
14 Participants
|
3 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 0 Vaccination · Grade 2
|
—
|
3 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
6 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 0 Vaccination · Grade 0
|
—
|
125 Participants
|
—
|
—
|
—
|
—
|
508 Participants
|
636 Participants
|
96 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 0 Vaccination · Grade 1
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
27 Participants
|
37 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 0 Vaccination · Grade 2
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
23 Participants
|
18 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 0 Vaccination · Grade 0
|
—
|
132 Participants
|
—
|
—
|
—
|
—
|
517 Participants
|
657 Participants
|
93 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 0 Vaccination · Grade 1
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
33 Participants
|
23 Participants
|
4 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 0 Vaccination · Grade 2
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
11 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 0 Vaccination · Grade 0
|
—
|
96 Participants
|
—
|
—
|
—
|
—
|
389 Participants
|
518 Participants
|
79 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 0 Vaccination · Grade 1
|
—
|
32 Participants
|
—
|
—
|
—
|
—
|
144 Participants
|
135 Participants
|
15 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 0 Vaccination · Grade 2
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
24 Participants
|
36 Participants
|
4 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
532 Participants
|
0 Participants
|
96 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
509 Participants
|
0 Participants
|
94 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
22 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
11 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
513 Participants
|
0 Participants
|
90 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
24 Participants
|
0 Participants
|
5 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
5 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 1 Vaccination · Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
403 Participants
|
0 Participants
|
74 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 1 Vaccination · Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
115 Participants
|
0 Participants
|
19 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 1 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
24 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 1 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 1 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 1 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 0 Vaccination · Grade 0
|
—
|
127 Participants
|
—
|
—
|
—
|
—
|
488 Participants
|
621 Participants
|
88 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 0 Vaccination · Grade 1
|
—
|
8 Participants
|
—
|
—
|
—
|
—
|
48 Participants
|
45 Participants
|
7 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 0 Vaccination · Grade 2
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
22 Participants
|
23 Participants
|
3 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 0 Vaccination · Grade 0
|
—
|
134 Participants
|
—
|
—
|
—
|
—
|
511 Participants
|
639 Participants
|
90 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 0 Vaccination · Grade 1
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
37 Participants
|
36 Participants
|
5 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 0 Vaccination · Grade 2
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
10 Participants
|
15 Participants
|
4 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 0 Vaccination · Grade 0
|
—
|
140 Participants
|
—
|
—
|
—
|
—
|
540 Participants
|
660 Participants
|
97 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 0 Vaccination · Grade 1
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
11 Participants
|
19 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 0 Vaccination · Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
7 Participants
|
10 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 0 Vaccination · Grade 0
|
—
|
106 Participants
|
—
|
—
|
—
|
—
|
435 Participants
|
557 Participants
|
85 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 0 Vaccination · Grade 1
|
—
|
29 Participants
|
—
|
—
|
—
|
—
|
96 Participants
|
104 Participants
|
11 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 0 Vaccination · Grade 2
|
—
|
7 Participants
|
—
|
—
|
—
|
—
|
26 Participants
|
28 Participants
|
3 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 0 Vaccination · Grade 0
|
—
|
109 Participants
|
—
|
—
|
—
|
—
|
443 Participants
|
558 Participants
|
84 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 0 Vaccination · Grade 1
|
—
|
27 Participants
|
—
|
—
|
—
|
—
|
86 Participants
|
91 Participants
|
9 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 0 Vaccination · Grade 2
|
—
|
6 Participants
|
—
|
—
|
—
|
—
|
29 Participants
|
39 Participants
|
5 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 0 Vaccination · Grade 0
|
—
|
118 Participants
|
—
|
—
|
—
|
—
|
469 Participants
|
606 Participants
|
86 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 0 Vaccination · Grade 1
|
—
|
18 Participants
|
—
|
—
|
—
|
—
|
64 Participants
|
60 Participants
|
7 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 0 Vaccination · Grade 2
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
25 Participants
|
22 Participants
|
5 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 0 Vaccination · Grade 3
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 0 Vaccination · Missing
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 0 Vaccination · Grade 0
|
—
|
131 Participants
|
—
|
—
|
—
|
—
|
507 Participants
|
633 Participants
|
92 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 0 Vaccination · Grade 1
|
—
|
9 Participants
|
—
|
—
|
—
|
—
|
36 Participants
|
38 Participants
|
6 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 0 Vaccination · Grade 2
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
15 Participants
|
19 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 0 Vaccination · Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 0 Vaccination · Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 7 days following Month 6 vaccinationPopulation: Participants in the safety subset who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected.
All solicited adverse events/reactogenicity symptoms are followed until resolution and graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, dated July 2017. Local reacto symptoms collected are: erythema/redness, induration/swelling, lymphadenopathy, and pain/tenderness. Systemic reacto symptoms collected are: arthralgia, chills, fever, headache, malaise/fatigue, myalgia, and nausea.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=1323 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=89 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
29 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
877 Participants
|
71 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
290 Participants
|
9 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
135 Participants
|
6 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
17 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Any Reacto After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1282 Participants
|
85 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
28 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Erythema/Redness After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1254 Participants
|
83 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
50 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
15 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Induration/Swelling After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1235 Participants
|
84 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
59 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
23 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Lymphadenopathy After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1010 Participants
|
76 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
244 Participants
|
7 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
56 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Pain/Tenderness After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1182 Participants
|
80 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
90 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
39 Participants
|
4 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
8 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Arthralgia After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1208 Participants
|
82 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
74 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
29 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
8 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Chills After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1282 Participants
|
86 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
26 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
8 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Fever After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1043 Participants
|
74 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
213 Participants
|
9 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
57 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Headache After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1076 Participants
|
76 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
164 Participants
|
7 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
70 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Malaise/Fatigue After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1136 Participants
|
79 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
124 Participants
|
5 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 6 Vaccination · Grade 2
|
—
|
—
|
—
|
—
|
—
|
—
|
52 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 6 Vaccination · Grade 3
|
—
|
—
|
—
|
—
|
—
|
—
|
7 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 6 Vaccination · Grade 4
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Myalgia After Month 6 Vaccination · Missing
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 6 Vaccination · Grade 0
|
—
|
—
|
—
|
—
|
—
|
—
|
1211 Participants
|
82 Participants
|
—
|
—
|
|
Part B: Number of Participants With Solicited Adverse Events in the Safety Subset
Nausea After Month 6 Vaccination · Grade 1
|
—
|
—
|
—
|
—
|
—
|
—
|
77 Participants
|
2 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days following Month 0 vaccination (all Study Groups) and up to 28 days following Month 1 vaccination (Study Groups 1 and 3)Population: Safety subset.
All unsolicited AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=142 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=558 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=692 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=99 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Mild
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
16 Participants
|
7 Participants
|
1 Participants
|
—
|
|
Part A: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Moderate
|
—
|
5 Participants
|
—
|
—
|
—
|
—
|
30 Participants
|
17 Participants
|
7 Participants
|
—
|
|
Part A: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Severe
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
6 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Part A: Number of Participants With Unsolicited Adverse Events in the Safety Subset
None
|
—
|
134 Participants
|
—
|
—
|
—
|
—
|
506 Participants
|
668 Participants
|
91 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days following Month 6 vaccinationPopulation: Participants in the safety subset who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected.
All unsolicited AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=1323 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=89 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset
None
|
—
|
—
|
—
|
—
|
—
|
—
|
1290 Participants
|
87 Participants
|
—
|
—
|
|
Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Mild
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Moderate
|
—
|
—
|
—
|
—
|
—
|
—
|
17 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Severe
|
—
|
—
|
—
|
—
|
—
|
—
|
5 Participants
|
1 Participants
|
—
|
—
|
|
Part B: Number of Participants With Unsolicited Adverse Events in the Safety Subset
Death
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 6Population: FAS
An SAE is any AE that results in any of the following outcomes: death, a life-threatening adverse event, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, or is medically important.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=1673 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=3740 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=7941 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=648 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Serious Adverse Events (SAEs)
|
—
|
32 Participants
|
—
|
—
|
—
|
—
|
84 Participants
|
126 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Day of Month 6 vaccination up to Month 18Population: Participants who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected (FM6 cohort).
An SAE is any AE that results in any of the following outcomes: death, a life-threatening adverse event, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, or is medically important.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=11243 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=2012 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Serious Adverse Events (SAEs)
|
—
|
—
|
—
|
—
|
—
|
—
|
212 Participants
|
45 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Month 6Population: FAS
Adverse events of special interest (AESI) were described in Appendix L of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=1673 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=3740 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=7941 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=648 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Adverse Events of Special Interest (AESIs)
|
—
|
19 Participants
|
—
|
—
|
—
|
—
|
36 Participants
|
59 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: Day of Month 6 vaccination up to Month 18Population: Participants who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected (FM6 cohort).
Adverse events of special interest (AESI) were described in Appendix L of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=11243 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=2012 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Adverse Events of Special Interest (AESIs)
|
—
|
—
|
—
|
—
|
—
|
—
|
111 Participants
|
27 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day after Month 0 dose until Month 6 dosePopulation: FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive.
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on the following criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. Because additional NAAT testing was performed at Month 1 for AG1 but not AG2-1, NAAT results at Month 1 were not considered. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and the date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=2867 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=9613 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With First CDC-based COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HIV Status
|
—
|
—
|
—
|
—
|
—
|
—
|
86 Participants
|
179 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day after Month 0 dose until Month 6 dosePopulation: FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive.
The COVE-based COVID-19 endpoint is defined as the first occurrence of adjudicated symptomatic NAAT-confirmed COVID-19 based on the following criteria (same as in the Moderna mRNA-1273 COVE trial): 1. At least TWO of the following systemic symptoms: Fever ≥ 38◦C), chills, myalgia, headache, sore throat, new loss of taste or smell, OR 2. At least ONE of the following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia, AND 3. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. The date of a COVID-19 endpoint is the later date of a symptom and the date of positive NAAT. The COVE criteria require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=2867 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=9613 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With First COVE-based COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HIV Statu
|
—
|
—
|
—
|
—
|
—
|
—
|
34 Participants
|
45 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 day after Month 0 dose until Month 6 dosePopulation: FAS. Participants who are baseline overall SARS-CoV-2 negative regardless of HIV status are comprised of Analysis Groups 1 and 3. Those who are baseline overall SARS-CoV-2 positive regardless of HIV status are comprised of Analysis Groups 2-1 and 4-1. Of note, overall SARS-CoV-2 status negative indicates all anti-Spike (anti-S), anti-Nucleocapsid (anti-N), and virus detection (NAAT) negative. Overall SARS-CoV-2 status positive indicates one of anti-S, anti-N, or NAAT positive.
The COVE-based severe COVID-19 endpoint is defined as the first occurrence of a confirmed case of COVE-based COVID-19, plus any of the following: 1. Clinical signs indicative of severe systemic illness, Respiratory Rate ≥ 30 per minute, Heart Rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 less than 300 mm Hg, OR 2. Respiratory failure or Acute Respiratory Distress Syndrome (ARDS), (defined as needing high-flow oxygen, noninvasive or mechanical ventilation, or ECMO), evidence of shock (systolic blood pressure less than 90 mmHg, diastolic BP less than 60 mmHg or requiring vasopressors), OR 3. Significant acute renal, hepatic, or neurologic dysfunction, OR 4. Admission to an intensive care unit or death. The severe COVE criteria require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=2867 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=9613 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With First COVE-based Severe COVID-19 Occurrence From 1 Day After Month 0 Dose to Month 6 Dose in FAS Cohort, Comparing Baseline SARS-CoV-2 Negative vs Positive, Regardless of HI
|
—
|
—
|
—
|
—
|
—
|
—
|
7 Participants
|
6 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Month 6 dose until end of follow up (up to 18 months)Population: Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort) and have Month 6 hybrid immunity. Hybrid immunity is defined as any evidence of prior SARS-CoV-2 infection up to the Month 6 visit, defined by meeting any of the following criteria: 1) baseline overall SARS-CoV-2 status positive, 2) at least one NAAT result at or prior to Month 6 is positive, or 3) at least one anti-NP tests at or prior to Month 6 is positive.
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on these criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=1732 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=1759 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Who Have Month 6 Hybrid Immunity Between Month 6 Monovalent and Bivalent Boost Groups
|
—
|
—
|
—
|
—
|
—
|
—
|
140 Participants
|
123 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Month 6 dose until end of follow up (up to 18 months)Population: Participants in FAS who received a Month 6 vaccination under the randomization scheme (RM6 cohort) and have Month 6 vaccine immunity. Vaccine immunity is defined as absence of evidence of prior SARS-C
The CDC-based COVID-19 endpoint is defined as the first occurrence of symptomatic NAAT-confirmed COVID-19 based on these criteria: 1. At least ONE of the following systemic or respiratory symptoms: Fever (≥ 38C), chills, cough, shortness of breath and/or difficulty breathing, fatigue, muscle and/or body aches \[not related to exercise\], headache, new loss of taste/smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea, AND 2. At least ONE (post-baseline) nasal swab (or respiratory sample, if hospitalized) positive for SARS-CoV-2 by NAAT. 3. The symptom date and NAAT positive date must be within 14 days of each other. The date of a COVID-19 endpoint according to the CDC-based definition is the earlier date of a symptom and date of positive NAAT that satisfy the criteria stated above. The CDC criteria do not require adjudication.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=244 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=253 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With a First Occurrence of CDC-based COVID-19 Starting 14 Days After Month 6 Dose Until End of Follow up in RM6 Cohort Who Have Month 6 Vaccine Immunity Between Month 6 Monovalent and Bivalent Boost Group
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
19 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Month 0, 4 weeks post final pre-Month 6 vaccination (peak timepoint)Population: Per-protocol serum immunogenicity set with antibody marker data available at Month 0 and peak timepoint. Hybrid immunity is defined by one pre-Month 6 immunization after natural infection. Vaccine-induced immunity is defined by two pre-Month 6 immunizations for baseline overall SARS-CoV-2 negative ppts. The purpose is to summarize NAb responses by vaccine regimen (hybrid vs vaccine), as well as within people living with HIV (PWH) and people living without HIV (PWoH) respectively.
Linear regression is used to provide covariate-adjusted point and 95% confidence interval estimation of geometric mean titers. Covariates adjusted are HIV status at baseline, age, sex at birth, and BMI.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=92 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
n=86 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
n=29 Participants
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=287 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=115 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=195 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody (NAb) Assay
Peak nAb-ID50 BA.4/5
|
—
|
4986 AU/ml
Interval 2986.0 to 8350.0
|
996 AU/ml
Interval 557.0 to 1726.0
|
326 AU/ml
Interval 202.0 to 533.0
|
—
|
—
|
4904 AU/ml
Interval 3502.0 to 6846.0
|
705 AU/ml
Interval 460.0 to 1065.0
|
5474 AU/ml
Interval 3101.0 to 9417.0
|
—
|
|
Part A: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody (NAb) Assay
Month 0 nAb-ID50 BA.4/5
|
—
|
372 AU/ml
Interval 227.0 to 583.0
|
9 AU/ml
Interval 7.0 to 14.0
|
9 AU/ml
Interval 6.0 to 15.0
|
—
|
—
|
348 AU/ml
Interval 265.0 to 459.0
|
9 AU/ml
Interval 7.0 to 12.0
|
324 AU/ml
Interval 219.0 to 477.0
|
—
|
SECONDARY outcome
Timeframe: Month 0, 4 weeks post final pre-Month 6 vaccination (peak timepoint)Population: Per-protocol serum immunogenicity set with antibody marker data available at Month 0 and peak timepoint. Hybrid immunity is defined by one pre-Month 6 immunization after natural infection. Vaccine-induced immunity is defined by two pre-Month 6 immunizations for baseline overall SARS-CoV-2 negative ppts. The purpose is to summarize NAb responses by vaccine regimen (hybrid vs vaccine), as well as within people living with HIV (PWH) and people living without HIV (PWoH) respectively.
Linear regression is used to provide covariate-adjusted point and 95% confidence interval estimation of geometric mean titers. Covariates adjusted are HIV status at baseline, age, sex at birth, and BMI.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=92 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
n=86 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
n=29 Participants
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=287 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=115 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=195 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Meso Scale Discovery-electrochemiluminescence Assay (MSD-ECL)
Month 0 IgG N Index
|
—
|
48473 AU/ml
Interval 33007.0 to 71126.0
|
4822 AU/ml
Interval 3226.0 to 7397.0
|
5977 AU/ml
Interval 4926.0 to 7573.0
|
—
|
—
|
52023 AU/ml
Interval 38843.0 to 68767.0
|
5978 AU/ml
Interval 4191.0 to 8489.0
|
52088 AU/ml
Interval 33740.0 to 79760.0
|
—
|
|
Part A: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Meso Scale Discovery-electrochemiluminescence Assay (MSD-ECL)
Month 0 IgG Spike BA.5
|
—
|
18066 AU/ml
Interval 12261.0 to 25693.0
|
818 AU/ml
Interval 546.0 to 1223.0
|
161 AU/ml
Interval 129.0 to 196.0
|
—
|
—
|
17481 AU/ml
Interval 13885.0 to 21634.0
|
480 AU/ml
Interval 344.0 to 657.0
|
14893 AU/ml
Interval 10481.0 to 21032.0
|
—
|
|
Part A: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Meso Scale Discovery-electrochemiluminescence Assay (MSD-ECL)
Peak IgG Spike BA.5
|
—
|
232660 AU/ml
Interval 170309.0 to 314805.0
|
130327 AU/ml
Interval 99833.0 to 167232.0
|
77390 AU/ml
Interval 65364.0 to 93101.0
|
—
|
—
|
205247 AU/ml
Interval 178321.0 to 236883.0
|
126285 AU/ml
Interval 102488.0 to 156924.0
|
188439 AU/ml
Interval 159506.0 to 224439.0
|
—
|
SECONDARY outcome
Timeframe: Month 0Population: Per-protocol PBMC immunogenicity set with cellular marker data available at Month 0. Hybrid immunity is defined by one pre-Month 6 immunization after natural infection. Vaccine-induced immunity is defined by two pre-Month 6 immunizations for baseline overall SARS-CoV-2 negative ppts. The purpose is to summarize NAb responses by vaccine regimen (hybrid vs vaccine), as well as within people living with HIV (PWH) and people living without HIV (PWoH) respectively.
Linear regression is used to provide covariate-adjusted point and 95% confidence interval estimation of geometric mean titers. Covariates adjusted are HIV status at baseline, age, sex at birth, and BMI.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=57 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=118 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=50 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=61 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Month 0
Month 0 CD4+ IFNg/IL2 in response to Spike BA.4/5
|
—
|
0.0469 % T-cells
Interval 0.0381 to 0.0573
|
—
|
—
|
—
|
—
|
0.051 % T-cells
Interval 0.0427 to 0.0601
|
0.0212 % T-cells
Interval 0.0165 to 0.0272
|
0.0593 % T-cells
Interval 0.0431 to 0.0804
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Month 0
Month 0 CD4+ IFNg/IL2/CD154 in response to BA.4-5 N
|
—
|
0.0491 % T-cells
Interval 0.0398 to 0.0609
|
—
|
—
|
—
|
—
|
0.0568 % T-cells
Interval 0.0475 to 0.068
|
0.0256 % T-cells
Interval 0.0194 to 0.0342
|
0.0671 % T-cells
Interval 0.0464 to 0.0998
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Month 0
Month 0 CD4+ IFNg/IL2/CD154 in response to Spike BA.4/5
|
—
|
0.0737 % T-cells
Interval 0.0595 to 0.0897
|
—
|
—
|
—
|
—
|
0.0757 % T-cells
Interval 0.0638 to 0.0896
|
0.0298 % T-cells
Interval 0.0226 to 0.039
|
0.0807 % T-cells
Interval 0.0573 to 0.109
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Month 0
Month 0 CD8+ IFNg/IL2 in response to BA.4-5 N
|
—
|
0.0264 % T-cells
Interval 0.0206 to 0.0347
|
—
|
—
|
—
|
—
|
0.025 % T-cells
Interval 0.0205 to 0.0307
|
0.0149 % T-cells
Interval 0.0126 to 0.0183
|
0.0229 % T-cells
Interval 0.0162 to 0.0333
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Month 0
Month 0 CD8+ IFNg/IL2 in response to Spike BA.4/5
|
—
|
0.0328 % T-cells
Interval 0.0238 to 0.0459
|
—
|
—
|
—
|
—
|
0.0314 % T-cells
Interval 0.0249 to 0.0401
|
0.0149 % T-cells
Interval 0.0123 to 0.0183
|
0.0287 % T-cells
Interval 0.0219 to 0.0384
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Month 0
Month 0 CD4+ IFNg/IL2 in response to BA.4-5 N
|
—
|
0.035 % T-cells
Interval 0.0283 to 0.0434
|
—
|
—
|
—
|
—
|
0.0418 % T-cells
Interval 0.0352 to 0.0505
|
0.0201 % T-cells
Interval 0.0159 to 0.0257
|
0.0514 % T-cells
Interval 0.0359 to 0.0762
|
—
|
SECONDARY outcome
Timeframe: 4 weeks post final pre-Month 6 vaccination (peak timepoint)Population: Per-protocol PBMC immunogenicity set with cellular marker data available at Month 0. Hybrid immunity is defined by one pre-Month 6 immunization after natural infection. Vaccine-induced immunity is defined by two pre-Month 6 immunizations for baseline overall SARS-CoV-2 negative ppts. The purpose is to summarize NAb responses by vaccine regimen (hybrid vs vaccine), as well as within people living with HIV (PWH) and people living without HIV (PWoH) respectively.
Linear regression is used to provide covariate-adjusted point and 95% confidence interval estimation of geometric mean titers. Covariates adjusted are HIV status at baseline, age, sex at birth, and BMI.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=57 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
n=29 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
n=21 Participants
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=118 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=50 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=61 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Peak Timepoint
Peak CD4+ IFNg/IL2 in response to BA.4-5 N
|
—
|
0.0354 % T-cells
Interval 0.0293 to 0.0431
|
0.0269 % T-cells
Interval 0.0178 to 0.0418
|
0.0135 % T-cells
Interval 0.012 to 0.0156
|
—
|
—
|
0.0396 % T-cells
Interval 0.0339 to 0.0468
|
0.0178 % T-cells
Interval 0.0145 to 0.0223
|
0.0459 % T-cells
Interval 0.034 to 0.0638
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Peak Timepoint
Peak CD4+ IFNg/IL2 in response to Spike BA.4/5
|
—
|
0.214 % T-cells
Interval 0.1766 to 0.2565
|
0.2463 % T-cells
Interval 0.1331 to 0.4461
|
0.1704 % T-cells
Interval 0.1539 to 0.1883
|
—
|
—
|
0.2226 % T-cells
Interval 0.1938 to 0.2531
|
0.2216 % T-cells
Interval 0.1525 to 0.3053
|
0.2364 % T-cells
Interval 0.1887 to 0.2925
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Peak Timepoint
Peak CD4+ IFNg/IL2/CD154 in response to BA.4-5 N
|
—
|
0.0513 % T-cells
Interval 0.0416 to 0.0631
|
0.0362 % T-cells
Interval 0.023 to 0.0585
|
0.0156 % T-cells
Interval 0.0137 to 0.018
|
—
|
—
|
0.0548 % T-cells
Interval 0.0465 to 0.0639
|
0.0242 % T-cells
Interval 0.0186 to 0.0314
|
0.0588 % T-cells
Interval 0.0433 to 0.0801
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Peak Timepoint
Peak CD4+ IFNg/IL2/CD154 in response to Spike BA.4/5
|
—
|
0.2681 % T-cells
Interval 0.2217 to 0.3192
|
0.3138 % T-cells
Interval 0.1734 to 0.5621
|
0.23 % T-cells
Interval 0.2069 to 0.2551
|
—
|
—
|
0.2786 % T-cells
Interval 0.2454 to 0.3163
|
0.2883 % T-cells
Interval 0.2077 to 0.3872
|
0.2943 % T-cells
Interval 0.2404 to 0.3537
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Peak Timepoint
Peak CD8+ IFNg/IL2 in response to BA.4-5 N
|
—
|
0.0254 % T-cells
Interval 0.0199 to 0.0321
|
0.0138 % T-cells
Interval 0.0116 to 0.0171
|
0.0157 % T-cells
Interval 0.0142 to 0.0179
|
—
|
—
|
0.024 % T-cells
Interval 0.0197 to 0.0296
|
0.0148 % T-cells
Interval 0.0127 to 0.0181
|
0.0222 % T-cells
Interval 0.0158 to 0.0322
|
—
|
|
Part A: Geometric Mean Titers of T-Cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay at Peak Timepoint
Peak CD8+ IFNg/IL2 in response to Spike BA.4/5
|
—
|
0.0527 % T-cells
Interval 0.0385 to 0.0733
|
0.0246 % T-cells
Interval 0.0176 to 0.036
|
0.028 % T-cells
Interval 0.021 to 0.0377
|
—
|
—
|
0.0481 % T-cells
Interval 0.0381 to 0.061
|
0.0359 % T-cells
Interval 0.0265 to 0.0478
|
0.0407 % T-cells
Interval 0.0305 to 0.0552
|
—
|
SECONDARY outcome
Timeframe: Months 6 and 7Population: Per-protocol serum immunogenicity set with antibody marker data available at Months 6 and 7. Hybrid immunity is defined by one pre-Month 6 immunization after natural infection. Vaccine-induced immunity is defined by two pre-Month 6 immunizations for baseline overall SARS-CoV-2 negative ppts.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=25 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=74 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=26 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=75 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 6 ID50 Titer to BA.4/5
|
—
|
390.3 AU/ml
Interval 189.6 to 803.5
|
—
|
—
|
—
|
—
|
750 AU/ml
Interval 545.1 to 1031.9
|
1121.4 AU/ml
Interval 603.5 to 2083.7
|
970.4 AU/ml
Interval 709.8 to 1326.6
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 6 ID50 Titer to XBB.1.5
|
—
|
80.1 AU/ml
Interval 38.9 to 164.9
|
—
|
—
|
—
|
—
|
124.8 AU/ml
Interval 86.0 to 181.1
|
169.2 AU/ml
Interval 99.5 to 287.8
|
194 AU/ml
Interval 127.9 to 294.3
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 6 ID80 Titer to BA.4/5
|
—
|
72.8 AU/ml
Interval 38.7 to 136.9
|
—
|
—
|
—
|
—
|
127 AU/ml
Interval 97.3 to 165.7
|
174.5 AU/ml
Interval 93.9 to 324.2
|
150.4 AU/ml
Interval 110.0 to 205.6
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 6 ID80 Titer to XBB.1.5
|
—
|
21.9 AU/ml
Interval 11.6 to 41.2
|
—
|
—
|
—
|
—
|
26.1 AU/ml
Interval 19.0 to 35.9
|
34.4 AU/ml
Interval 22.1 to 53.5
|
38.2 AU/ml
Interval 26.5 to 55.0
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 7 ID50 Titer to BA.4/5
|
—
|
1915.1 AU/ml
Interval 849.9 to 4315.1
|
—
|
—
|
—
|
—
|
2624.7 AU/ml
Interval 2019.1 to 3411.9
|
2326.5 AU/ml
Interval 1494.5 to 3621.6
|
4519.8 AU/ml
Interval 3299.2 to 6191.9
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 7 ID50 Titer to XBB.1.5
|
—
|
577.6 AU/ml
Interval 234.2 to 1424.4
|
—
|
—
|
—
|
—
|
542.4 AU/ml
Interval 375.7 to 783.1
|
607.9 AU/ml
Interval 327.2 to 1129.5
|
1521.5 AU/ml
Interval 1000.0 to 2315.0
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 7 ID80 Titer to BA.4/5
|
—
|
369.3 AU/ml
Interval 179.4 to 760.3
|
—
|
—
|
—
|
—
|
546.9 AU/ml
Interval 420.7 to 710.9
|
511.5 AU/ml
Interval 300.8 to 869.9
|
1033.6 AU/ml
Interval 754.5 to 1416.0
|
—
|
|
Part B: Geometric Mean Titers (GMTs) of SARS-CoV-2 Antibodies as Measured by Neutralizing Antibody Assay
Month 7 ID80 Titer to XBB.1.5
|
—
|
115.5 AU/ml
Interval 46.8 to 284.8
|
—
|
—
|
—
|
—
|
122.3 AU/ml
Interval 84.7 to 176.6
|
126.8 AU/ml
Interval 74.6 to 215.7
|
326.5 AU/ml
Interval 214.6 to 496.8
|
—
|
SECONDARY outcome
Timeframe: Participants testing positive for SARS-CoV-2 had additional nasab swabs taken fortnightly until testing negative, up to a maximum of 18 monthsPopulation: Participants who are NAAT+ in the FAS cohort in part A. Participants who are NAAT+ in the RM6 cohort in part B.
Participants were considered to have persistent SARS-CoV-2 NAAT positivity if they had positive swabs lasting \>= 50 days during a single infection. A single infection was assumed unless the participant had a positive NAAT following either a single negative NAAT by \>= 90 days or two consecutive negative NAATs over any time interval, in which case it was considered a reinfection. In Part A, the first NAAT+ on or before the Month 6 dose for each ppt was considered. In Part B, the first NAAT+ after the Month 6 dose for each ppt was considered. Analysis of viral evolution was not done due to termination of resources for evaluation.
Outcome measures
| Measure |
Part B (Blinded): HIV- Bivalent
n=46 Participants
Participants who are baseline HIV negative and received mRNA1273.222 at Month 6
|
Part A (Open-label): Study Group 3, Analysis Group 3 (AG3)
n=27 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status negative
|
Part A (Open-label): Study Group 3, Analysis Group 4-2 (AG4-2)
n=52 Participants
Participants in Study Group 3 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part A (Open-label): Study Group 4, Analysis Group 4-1 (AG4-1)
n=132 Participants
Participants in Study Group 4 who are baseline HIV negative and overall SARS-CoV-2 status positive
|
Part B (Blinded): HIV+ Monovalent
n=229 Participants
Participants who are baseline HIV positive and received mRNA1273 at Month 6
|
Part B (Blinded): HIV+ Bivalent
n=200 Participants
Participants who are baseline HIV positive and received mRNA1273.222 at Month 6
|
Part A (Open-label): Analysis Group 1 (AG1) + Analysis Group 3 (AG3)
n=220 Participants
Participants who are overall SARS-CoV-2 negative at baseline regardless of HIV status
|
Part A (Open-label): Analysis Group 2-1 (AG2-1) + Analysis Group 4-1 (AG4-1)
n=333 Participants
Participants who are overall SARS-CoV-2 positive at baseline regardless of HIV status
|
Part A (Open-label): Study Group 3
n=597 Participants
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part B (Blinded): HIV- Monovalent
n=55 Participants
Participants who are baseline HIV negative and received mRNA1273 at Month 6
|
|---|---|---|---|---|---|---|---|---|---|---|
|
SARS-CoV-2 Viral Persistence and Evolution Among Participants Virologically Diagnosed With SARS-CoV-2
|
0 percentage of participants
Interval 0.0 to 7.71
|
0 percentage of participants
Interval 0.0 to 12.46
|
3.85 percentage of participants
Interval 1.06 to 12.98
|
0.76 percentage of participants
Interval 0.13 to 4.17
|
1.31 percentage of participants
Interval 0.45 to 3.78
|
0 percentage of participants
Interval 0.0 to 1.88
|
2.27 percentage of participants
Interval 0.97 to 5.21
|
3.3 percentage of participants
Interval 1.85 to 5.82
|
1.17 percentage of participants
Interval 0.57 to 2.4
|
0 percentage of participants
Interval 0.0 to 6.53
|
Adverse Events
Part A (Open-label): Study Group 1
Serious events: 84 serious events
Other events: 308 other events
Deaths: 24 deaths
Part A (Open Label): Study Group 2
Serious events: 126 serious events
Other events: 270 other events
Deaths: 31 deaths
Part A (Open-label): Study Group 3
Serious events: 5 serious events
Other events: 47 other events
Deaths: 1 deaths
Part A (Open-label): Study Group 4
Serious events: 32 serious events
Other events: 62 other events
Deaths: 9 deaths
Part B (Blinded): mRNA-1273 at Month 6
Serious events: 212 serious events
Other events: 450 other events
Deaths: 63 deaths
Part B (Blinded): mRNA-1273.222 at Month 6
Serious events: 45 serious events
Other events: 15 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Part A (Open-label): Study Group 1
n=558 participants at risk；n=3740 participants at risk
Baseline HIV positive, baseline SARS-CoV-2 anti-S negative
|
Part A (Open Label): Study Group 2
n=692 participants at risk；n=7941 participants at risk
Baseline HIV positive, baseline SARS-CoV-2 anti-S positive
|
Part A (Open-label): Study Group 3
n=99 participants at risk；n=648 participants at risk
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part A (Open-label): Study Group 4
n=142 participants at risk；n=1672 participants at risk
Baseline HIV negative, baseline SARS-CoV-2 anti-S positive
|
Part B (Blinded): mRNA-1273 at Month 6
n=1323 participants at risk；n=11243 participants at risk
Received monovalent booster at Month 6
|
Part B (Blinded): mRNA-1273.222 at Month 6
n=89 participants at risk；n=2012 participants at risk
Received bivalent booster at Month 6
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
3/3740 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
3/11243 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
3/11243 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
2/3740 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Congenital, familial and genetic disorders
Congenital anomaly in offspring
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Congenital, familial and genetic disorders
Fanconi syndrome
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.05%
2/3740 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.05%
2/3740 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
3/11243 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.08%
3/3740 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Death
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.12%
13/11243 • Number of events 13 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.20%
4/2012 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Abortion infected
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Bone tuberculosis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Complicated malaria
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Device related infection
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Dysentery
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Enterocolitis AIDS
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Extrapulmonary Tuberculosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Extrapulmonary tuberculosis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
3/7941 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Eye infection syphilitic
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Gastroenteritis
|
0.11%
4/3740 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.07%
8/11243 • Number of events 8 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
HIV peripheral neuropathy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
HIV wasting syndrome
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
HIV-associated neurocognitive disorder
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Infection
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.05%
2/3740 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Malaria
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.07%
8/11243 • Number of events 8 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Male genital tract tuberculosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
4/11243 • Number of events 5 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Meningitis meningococcal
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Meningoencephalitis bacterial
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
1/648 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pelvic sepsis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pneumonia
|
0.24%
9/3740 • Number of events 9 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
6/7941 • Number of events 6 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.18%
3/1672 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.12%
13/11243 • Number of events 13 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.10%
2/2012 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Post procedural sepsis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.05%
2/3740 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
12/7941 • Number of events 12 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.07%
8/11243 • Number of events 8 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Sepsis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Syphilis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
4/11243 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Tuberculosis gastrointestinal
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Viral hepatitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
1/648 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
4/11243 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Epidural haemorrhage
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
3/7941 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.10%
2/2012 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.10%
2/2012 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Perineal injury
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
4/11243 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.12%
2/1672 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
5/11243 • Number of events 5 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.10%
2/2012 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
1/648 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.18%
3/1672 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
1/648 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.05%
2/3740 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma AIDS related
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage IV
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
1/648 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Brain stem syndrome
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.08%
3/3740 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.12%
2/1672 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Headache
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Post-traumatic epilepsy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Radial nerve palsy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Seizure
|
0.08%
3/3740 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
4/7941 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Syncope
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
6/7941 • Number of events 6 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
4/11243 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.10%
2/2012 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complicated
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
False labour
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Retained products of conception
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
4/11243 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.10%
2/2012 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Alcohol use disorder
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Conversion disorder
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Factitious disorder
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
3/7941 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
1/648 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
3/11243 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.04%
5/11243 • Number of events 5 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.05%
1/2012 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.03%
1/3740 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.06%
1/1672 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Social circumstances
Physical assault
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/11243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.03%
2/7941 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.02%
2/11243 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/7941 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.12%
2/1672 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/3740 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/7941 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/648 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1672 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.01%
1/11243 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/2012 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
Other adverse events
| Measure |
Part A (Open-label): Study Group 1
n=558 participants at risk；n=3740 participants at risk
Baseline HIV positive, baseline SARS-CoV-2 anti-S negative
|
Part A (Open Label): Study Group 2
n=692 participants at risk；n=7941 participants at risk
Baseline HIV positive, baseline SARS-CoV-2 anti-S positive
|
Part A (Open-label): Study Group 3
n=99 participants at risk；n=648 participants at risk
Baseline HIV negative, baseline SARS-CoV-2 anti-S negative
|
Part A (Open-label): Study Group 4
n=142 participants at risk；n=1672 participants at risk
Baseline HIV negative, baseline SARS-CoV-2 anti-S positive
|
Part B (Blinded): mRNA-1273 at Month 6
n=1323 participants at risk；n=11243 participants at risk
Received monovalent booster at Month 6
|
Part B (Blinded): mRNA-1273.222 at Month 6
n=89 participants at risk；n=2012 participants at risk
Received bivalent booster at Month 6
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Blood and lymphatic system disorders
Lymphadenopathy (Solicited)
|
11.5%
64/558 • Number of events 70 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
4.9%
34/692 • Number of events 34 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
9.1%
9/99 • Number of events 13 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
7.0%
10/142 • Number of events 10 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
6.3%
84/1323 • Number of events 84 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
2.2%
2/89 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Eye disorders
Episcleritis
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.70%
1/142 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Eye disorders
Eyelid rash
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.36%
2/558 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.70%
1/142 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
14.7%
82/558 • Number of events 92 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
8.4%
58/692 • Number of events 58 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
13.1%
13/99 • Number of events 17 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
7.7%
11/142 • Number of events 11 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
8.2%
108/1323 • Number of events 108 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
4.5%
4/89 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Chills (Solicited)
|
14.7%
82/558 • Number of events 95 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
7.5%
52/692 • Number of events 52 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
12.1%
12/99 • Number of events 17 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
5.6%
8/142 • Number of events 8 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
8.4%
111/1323 • Number of events 111 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
4.5%
4/89 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Fatigue
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Fatigue (Solicited)
|
31.9%
178/558 • Number of events 229 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
19.2%
133/692 • Number of events 133 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
27.3%
27/99 • Number of events 37 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
23.2%
33/142 • Number of events 33 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
18.4%
243/1323 • Number of events 243 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
11.2%
10/89 • Number of events 10 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Influenza like illness
|
0.90%
5/558 • Number of events 5 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.70%
1/142 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.30%
4/1323 • Number of events 5 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Injection site pain
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Mass
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Pain
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Pain (Solicited)
|
39.6%
221/558 • Number of events 308 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
25.0%
173/692 • Number of events 173 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
34.3%
34/99 • Number of events 43 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
32.4%
46/142 • Number of events 46 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
23.4%
309/1323 • Number of events 309 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
11.2%
10/89 • Number of events 10 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
General disorders
Swelling (Solicited)
|
12.9%
72/558 • Number of events 83 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
7.9%
55/692 • Number of events 55 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
4.0%
4/99 • Number of events 6 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
12.0%
17/142 • Number of events 17 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
4.9%
65/1323 • Number of events 65 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
3.4%
3/89 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Immune system disorders
Hypersensitivity
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Dysentery
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Gastroenteritis
|
0.36%
2/558 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Gingivitis
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
2.2%
2/89 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Malaria
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pharyngitis
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.23%
3/1323 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Sexually transmitted disease
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Tinea faciei
|
0.36%
2/558 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
8/558 • Number of events 8 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.43%
3/692 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.4%
2/142 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.70%
1/142 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Injury, poisoning and procedural complications
Wound
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Investigations
Blood pressure increased
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Investigations
Body temperature increased (Solicited)
|
5.4%
30/558 • Number of events 33 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
4.5%
31/692 • Number of events 31 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
5.1%
5/99 • Number of events 6 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.4%
2/142 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
2.8%
37/1323 • Number of events 37 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
2/1323 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
20.1%
112/558 • Number of events 130 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
10.1%
70/692 • Number of events 70 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
17.2%
17/99 • Number of events 23 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
10.6%
15/142 • Number of events 15 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
10.4%
137/1323 • Number of events 137 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
6.7%
6/89 • Number of events 6 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Dizziness
|
0.54%
3/558 • Number of events 3 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.29%
2/692 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
23.3%
130/558 • Number of events 167 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
12.3%
85/692 • Number of events 85 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
18.2%
18/99 • Number of events 26 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
16.9%
24/142 • Number of events 24 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
13.8%
183/1323 • Number of events 183 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
7.9%
7/89 • Number of events 7 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.15%
2/1323 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Headache
|
0.36%
2/558 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.29%
2/692 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.4%
2/142 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.30%
4/1323 • Number of events 4 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Headache (Solicited)
|
32.6%
182/558 • Number of events 232 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
19.4%
134/692 • Number of events 134 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
25.3%
25/99 • Number of events 32 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
25.4%
36/142 • Number of events 36 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
20.9%
276/1323 • Number of events 276 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
13.5%
12/89 • Number of events 12 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Nervous system disorders
Paraesthesia
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.36%
2/558 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Erythema (Solicited)
|
5.9%
33/558 • Number of events 35 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
2.9%
20/692 • Number of events 20 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
5.1%
5/99 • Number of events 5 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
8.5%
12/142 • Number of events 12 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
2.8%
37/1323 • Number of events 37 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.1%
1/89 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.08%
1/1323 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.18%
1/558 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/142 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Vascular disorders
Hypertension
|
0.36%
2/558 • Number of events 2 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.14%
1/692 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
1.0%
1/99 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.70%
1/142 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/558 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/692 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/99 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.70%
1/142 • Number of events 1 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/1323 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
0.00%
0/89 • Solicited AEs were collected for 7 days following each vaccination. Unsolicited AEs were collected for 28 days following each vaccination. Serious AEs were collected until end of follow up (up to 18 months).
All cause mortality and serious AEs were collected and reported on all participants in the FAS cohort. Other AEs were collected and reported on safety subset participants in the FAS cohort for Part A and on safety subset participants in the FM6 cohort for Part B. In each AE table, AEs following Month 0 and/or Month 1 vaccination were reported for Part A and AEs following Month 6 vaccination were reported for Part B.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place