Trial Outcomes & Findings for The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01) (NCT NCT05012943)
NCT ID: NCT05012943
Last Updated: 2025-11-06
Results Overview
Solicited local ARs included injection site erythema, injection site pain, injection site induration/swelling, and injection site tenderness. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
19474 participants
Primary outcome timeframe
Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36)
Results posted on
2025-11-06
Participant Flow
As pre-specified, data were collected and are reported per vaccine group overall for all study phases combined. Data are reported per first treatment received.
Participant milestones
| Measure |
Placebo
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per initial treatment received. Data in this arm are presented pooled for participants who initially received placebo in Phases 1, 2, 3a, 3b.
|
ARCT-154
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per initial treatment received. Data in this arm are presented pooled for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b, 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8300
|
9992
|
1182
|
|
Overall Study
Phase 1: Received ARCT-154 D1-92
|
0
|
74
|
0
|
|
Overall Study
Phase 1: Received Placebo D1-92
|
26
|
0
|
0
|
|
Overall Study
Phase 1: Received Initially Placebo, ARCT-154 D92-EOS
|
23
|
0
|
0
|
|
Overall Study
Phase 1: Received Initially ARCT-154, Placebo D92-EOS
|
0
|
67
|
0
|
|
Overall Study
Phase 3b: Received ARCT-154 D1-92
|
0
|
8059
|
0
|
|
Overall Study
Phase 3b: Received Placebo D1-92
|
8041
|
0
|
0
|
|
Overall Study
Phase 3b: Received Initially Placebo, ARCT-154 D92-EOS
|
7350
|
0
|
0
|
|
Overall Study
Phase 3b: Received Initially ARCT-154, Placebo D92-EOS
|
0
|
7458
|
0
|
|
Overall Study
Phase 2: Received ARCT-154 D1-92
|
0
|
226
|
0
|
|
Overall Study
Phase 2: Received Placebo D1-92
|
75
|
0
|
0
|
|
Overall Study
Phase 3a: Received ARCT-154 D1-92
|
0
|
448
|
0
|
|
Overall Study
Phase 3a: Received Placebo D1-92
|
152
|
0
|
0
|
|
Overall Study
Phase 2 Received Initially Placebo, ARCT-154 D92-EOS
|
72
|
0
|
0
|
|
Overall Study
Phase 2 Received Initially ARCT-154, Placebo D92-EOS
|
0
|
55
|
0
|
|
Overall Study
Phase 3a Received Initially Placebo, ARCT-154 D92-EOS
|
137
|
0
|
0
|
|
Overall Study
Phase 3a Received Initially ARCT-154, Placebo D92-EOS
|
0
|
98
|
0
|
|
Overall Study
Phase 3C: Received ARCT-154
|
0
|
1186
|
0
|
|
Overall Study
Phase 2 Received Initially ARCT-154, ARCT-154 D92-EOS
|
0
|
159
|
0
|
|
Overall Study
Phase 3a Received initially ARCT-154, ARCT-154 D92-EOS
|
0
|
324
|
0
|
|
Overall Study
COMPLETED
|
7207
|
8942
|
1155
|
|
Overall Study
NOT COMPLETED
|
1093
|
1050
|
27
|
Reasons for withdrawal
| Measure |
Placebo
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per initial treatment received. Data in this arm are presented pooled for participants who initially received placebo in Phases 1, 2, 3a, 3b.
|
ARCT-154
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per initial treatment received. Data in this arm are presented pooled for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b, 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1052
|
1006
|
20
|
|
Overall Study
Death
|
25
|
17
|
4
|
|
Overall Study
Lost to Follow-up
|
11
|
24
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Other than Specified
|
2
|
1
|
0
|
Baseline Characteristics
The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01)
Baseline characteristics by cohort
| Measure |
ARCT-154
n=8807 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=8294 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
n=1186 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
n=1180 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
Total
n=19467 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.0 Years
n=49 Participants
|
48.0 Years
n=50 Participants
|
52.0 Years
n=50 Participants
|
52.0 Years
n=50 Participants
|
48.0 Years
n=12 Participants
|
|
Sex: Female, Male
Female
|
4441 Participants
n=49 Participants
|
4206 Participants
n=50 Participants
|
603 Participants
n=50 Participants
|
613 Participants
n=50 Participants
|
9863 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
4366 Participants
n=49 Participants
|
4088 Participants
n=50 Participants
|
583 Participants
n=50 Participants
|
567 Participants
n=50 Participants
|
9604 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
The Kinh
|
8757 Participants
n=49 Participants
|
8239 Participants
n=50 Participants
|
1185 Participants
n=50 Participants
|
1177 Participants
n=50 Participants
|
19358 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Other
|
50 Participants
n=49 Participants
|
55 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
109 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36)Population: Reactogenicity Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1) and provided at least 1 reactogenicity diary report. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. Number analyzed = number of participants with evaluable data at the specified timepoint.
Solicited local ARs included injection site erythema, injection site pain, injection site induration/swelling, and injection site tenderness. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
ARCT-154
n=8688 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=8151 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
n=1182 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
n=1180 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Local Adverse Reactions (ARs)
Dose 1
|
4060 Participants
|
909 Participants
|
467 Participants
|
416 Participants
|
|
Number of Participants Reporting Solicited Local Adverse Reactions (ARs)
Dose 2
|
2852 Participants
|
612 Participants
|
286 Participants
|
183 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after Dose 1 and Dose 2 (up to Day 7 and 36)Population: Reactogenicity Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1) and provided at least 1 reactogenicity diary report. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. Number analyzed = number of participants with evaluable data at the specified timepoint.
Solicited systemic ARs included arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, and nausea/vomiting. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
ARCT-154
n=8688 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=8151 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
n=1182 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
n=1180 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Reporting Solicited Systemic ARs
Dose 2
|
3718 Participants
|
1889 Participants
|
477 Participants
|
331 Participants
|
|
Number of Participants Reporting Solicited Systemic ARs
Dose 1
|
4375 Participants
|
2620 Participants
|
638 Participants
|
657 Participants
|
PRIMARY outcome
Timeframe: Approximately 28 days after Dose 1 and Dose 2 (Day 1 to Day 29 and Day 29 to Day 57)Population: Safety Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1). Participants were analyzed according to the study vaccine received. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint. Number analyzed = number of participants with evaluable data at the specified timepoint.
Unsolicited AEs were defined as any spontaneously reported or discovered AE. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
ARCT-154
n=8807 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=8294 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
n=1186 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
n=1180 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Dose 1
|
1323 Participants
|
1198 Participants
|
260 Participants
|
252 Participants
|
|
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Dose 2
|
1232 Participants
|
1311 Participants
|
226 Participants
|
225 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 92Population: Safety Analysis Set, all participants who received any dose of study vaccine (ARCT-154 or placebo or ChAdOx1). Participants were analyzed according to the study vaccine received. As pre-specified, data are presented pooled per treatment received for Phase 1/2/3a/3b, and separately for ARCT-154 for Phase 3c. Overall number of participants analyzed = number of participants evaluable for the endpoint.
An MAAE was defined as an AE that led to an unscheduled visit (including a telemedicine visit) with a healthcare provider (\[HCP\], e.g., nurse, nurse practitioner, physician's assistant, physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or was a congenital anomaly/birth defect arising from a pregnancy conceived after receipt of study vaccine. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
ARCT-154
n=8807 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=8294 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
n=1186 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
n=1180 Participants
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
MAAEs
|
1132 Participants
|
1284 Participants
|
148 Participants
|
146 Participants
|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
SAEs
|
133 Participants
|
217 Participants
|
22 Participants
|
35 Participants
|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs) and AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
6 Participants
|
18 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 57Population: Immunogenicity Analysis Set, all participants who received all protocol required doses of vaccine up to evaluation timepoint, no evidence of prior severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) infection at Day 1, at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=number of participants evaluable for the endpoint at the specified timepoint.
Data are presented for the number of participants with a NAb seroconversion response as determined by the surrogate virus neutralization test (sVNT). Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline.
Outcome measures
| Measure |
ARCT-154
n=699 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=231 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants With Neutralizing Antibody (NAb) Responses
|
658 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 36 to Day 92Population: Modified Intent-to-Treat (mITT) Analysis Set (Phase 3b), which included all participants who received all protocol-required doses of study vaccine up to the evaluation timepoint concerned, and who had no evidence of SARS-CoV-2 infection on Day 1 or up to 7 days after the 2nd study vaccination. As pre-specified, data are presented pooled per treatment received and for participants in Phase 3b only. Number of participants analyzed = those with evaluable data for this endpoint.
COVID-19 was defined as a positive SARS-CoV-2 test and at least one of the following that was a new or worsening finding: ⦁ Fever or chills ⦁ Cough ⦁ Shortness of breath or difficulty breathing ⦁ Fatigue ⦁ Muscle or body aches ⦁ Headache ⦁ New loss of taste or smell ⦁ Sore throat ⦁ Congestion or runny nose ⦁ Nausea or vomiting ⦁ Diarrhea Data are presented for the number of participants with a first occurrence of COVID-19 with no evidence of prior infection.
Outcome measures
| Measure |
ARCT-154
n=7762 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=7696 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants With a First Occurrence of Coronavirus Disease 2019 (COVID-19)
|
200 Participants
|
440 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 57 and 92Population: Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for endpoint. Number analyzed=participants with evaluable data at the specified timepoints.
Outcome measures
| Measure |
ARCT-154
n=724 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=242 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Geometric Mean Titers of SARS-CoV-2 Neutralizing Antibodies
Day 1
|
15.3 IU/mL
Interval 15.2 to 15.4
|
15.2 IU/mL
Interval 15.0 to 15.3
|
—
|
—
|
|
Geometric Mean Titers of SARS-CoV-2 Neutralizing Antibodies
Day 29
|
60.7 IU/mL
Interval 56.6 to 65.1
|
15.7 IU/mL
Interval 15.2 to 16.1
|
—
|
—
|
|
Geometric Mean Titers of SARS-CoV-2 Neutralizing Antibodies
Day 57
|
221.4 IU/mL
Interval 207.6 to 236.1
|
15.2 IU/mL
Interval 15.2 to 15.2
|
—
|
—
|
|
Geometric Mean Titers of SARS-CoV-2 Neutralizing Antibodies
Day 92
|
209.6 IU/mL
Interval 188.2 to 233.3
|
20.3 IU/mL
Interval 18.0 to 22.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 57, 92Population: Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for endpoint. Number analyzed=participants with evaluable data at the specified timepoints.
Outcome measures
| Measure |
ARCT-154
n=718 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=240 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise in SARS-CoV-2 Neutralizing Antibody Titers
Day 29
|
4.0 Ratio
Interval 3.7 to 4.3
|
1.0 Ratio
Interval 1.0 to 1.1
|
—
|
—
|
|
Geometric Mean Fold Rise in SARS-CoV-2 Neutralizing Antibody Titers
Day 57
|
14.5 Ratio
Interval 13.6 to 15.5
|
1.0 Ratio
Interval 1.0 to 1.0
|
—
|
—
|
|
Geometric Mean Fold Rise in SARS-CoV-2 Neutralizing Antibody Titers
Day 92
|
13.7 Ratio
Interval 12.3 to 15.3
|
1.3 Ratio
Interval 1.2 to 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 57 and 92Population: Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints.
Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline as measured by the sVNT test. Data are presented for the number of participants seroconverting for neutralizing antibodies.
Outcome measures
| Measure |
ARCT-154
n=718 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=240 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Seroconverting for Neutralizing Antibodies
Day 29
|
388 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Seroconverting for Neutralizing Antibodies
Day 57
|
658 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Seroconverting for Neutralizing Antibodies
Day 92
|
571 Participants
|
21 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 29, 57, 92Population: Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints.
Outcome measures
| Measure |
ARCT-154
n=725 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=242 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Geometric Mean Concentration of Spike Protein Immunoglobulin G (IgG) Binding Antibodies
Day 1
|
0.3 units (U)/ milliliter (mL)
Interval 0.3 to 0.3
|
0.3 units (U)/ milliliter (mL)
Interval 0.3 to 0.3
|
—
|
—
|
|
Geometric Mean Concentration of Spike Protein Immunoglobulin G (IgG) Binding Antibodies
Day 29
|
2.1 units (U)/ milliliter (mL)
Interval 2.0 to 2.3
|
0.3 units (U)/ milliliter (mL)
Interval 0.3 to 0.3
|
—
|
—
|
|
Geometric Mean Concentration of Spike Protein Immunoglobulin G (IgG) Binding Antibodies
Day 57
|
20.3 units (U)/ milliliter (mL)
Interval 19.0 to 21.7
|
0.3 units (U)/ milliliter (mL)
Interval 0.3 to 0.3
|
—
|
—
|
|
Geometric Mean Concentration of Spike Protein Immunoglobulin G (IgG) Binding Antibodies
Day 92
|
11.9 units (U)/ milliliter (mL)
Interval 10.6 to 13.3
|
0.4 units (U)/ milliliter (mL)
Interval 0.3 to 0.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 57, 92Population: Immunogenicity Analysis Set, all participants who received all protocol required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints.
Outcome measures
| Measure |
ARCT-154
n=719 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=240 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Geometric Mean Fold Ratio of Spike Protein IgG Binding Antibodies
Day 29
|
7.5 ratio
Interval 6.9 to 8.1
|
1.0 ratio
Interval 0.9 to 1.0
|
—
|
—
|
|
Geometric Mean Fold Ratio of Spike Protein IgG Binding Antibodies
Day 57
|
71.4 ratio
Interval 66.6 to 76.5
|
1.0 ratio
Interval 0.9 to 1.0
|
—
|
—
|
|
Geometric Mean Fold Ratio of Spike Protein IgG Binding Antibodies
Day 92
|
42.0 ratio
Interval 37.5 to 47.1
|
1.5 ratio
Interval 1.2 to 1.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 57, 92Population: Immunogenicity Analysis Set, all participants who received all protocol-required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phase 1, 2, 3a. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints.
Seroconversion was defined as a ≥4-fold increase in antibody concentration from baseline. Data are presented for the number of participants seroconverting for spike protein IgG binding antibodies.
Outcome measures
| Measure |
ARCT-154
n=719 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=240 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Seroconverting for Spike Protein IgG Binding Antibodies
Day 29
|
527 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Seroconverting for Spike Protein IgG Binding Antibodies
Day 57
|
698 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Seroconverting for Spike Protein IgG Binding Antibodies
Day 92
|
652 Participants
|
29 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29 and 57Population: Immunogenicity Analysis Set, all participants who received all protocol-required doses of study vaccine up to evaluation timepoint, no evidence of prior SARS-CoV-2 infection at Day 1, with at least 1 valid post-vaccination immunogenicity assay result. As pre-specified, data is pooled per treatment received for participants in Phases 1 and 2. Overall number of participants analyzed=participants evaluable for the endpoint. Number analyzed=participants with evaluable data at specified timepoints.
The plaque reduction neutralization test (PRNT) is a live virus assay. Neutralizing antibody titers were calculated as the highest serum dilution that resulted in 50% reduction in the number of virus plaques (PRNT50). Data presented is for the ancestral-clinical isolate variant. Data are presented for the number of participants that demonstrated seroconversion (as defined by 4-fold increase in neutralizing antibody concentration from baseline) on PRNT50.
Outcome measures
| Measure |
ARCT-154
n=111 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=37 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants Seroconverting on Neutralizing Antibody Responses by Plaque Reduction Neutralization Test at 50% Reduction (PRNT50)
Day 29
|
17 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Seroconverting on Neutralizing Antibody Responses by Plaque Reduction Neutralization Test at 50% Reduction (PRNT50)
Day 57
|
86 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 36 to Day 92Population: Modified Intent-to-Treat (mITT) Analysis Set (pooled for Phases 1/2/3a/3b), which included all participants who received all protocol-required doses of study vaccine up to the evaluation timepoint concerned, and who had no evidence of SARS-CoV-2 infection on Day 1 or up to 7 days after the 2nd study vaccination. As pre-specified, data are presented pooled per treatment received for participants in Phases 1/2/3a/3b only.
Number of participants with a first occurrence of severe COVID-19 in participants with no evidence of prior infection. Severe COVID-19 was defined as a positive SARS-CoV-2 test, symptoms per protocol-defined COVID-19 and any of the following: Clinical signs at rest indicative of severe systemic illness: - Respiratory rate ≥30 per minute, - Heart rate ≥125 per minute, - Oxygen saturation (SpO2) ≤93% on room air at sea level or partial pressure of oxygen (PO2)/fraction of inspired oxygen (FiO2) \<300 millimeter of mercury (mm Hg) - Respiratory failure (defined as needing high flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation \[ECMO\]); Evidence of shock: - Systolic blood pressure (SBP) \<90 mm Hg, or - Diastolic blood pressure (DBP) \<60 mm Hg, or requiring vasopressors, - Significant acute renal, hepatic, or neurologic dysfunction - Admission to an intensive care unit (ICU) - Death
Outcome measures
| Measure |
ARCT-154
n=8492 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=7940 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants With a First Occurrence of Severe COVID-19
|
2 Participants
|
43 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 36 to Day 92Population: Modified Intent-to-Treat (mITT) Analysis Set (pooled for Phases 1/2/3a/3b), which included all participants who received all protocol-required doses of study vaccine up to the evaluation timepoint concerned, and who had no evidence of SARS-CoV-2 infection on Day 1 or up to 7 days after the 2nd study vaccination. As pre-specified, data are presented pooled per treatment received for participants in Phases 1/2/3a/3b only.
Number of participants with death due to COVID-19 in participants with no evidence of prior infection.
Outcome measures
| Measure |
ARCT-154
n=8492 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=7940 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants With Death Due to COVID-19
|
1 Participants
|
9 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 36 to Day 92Population: Modified Intent-to-Treat (mITT) Analysis Set (pooled for Phases 1/2/3a/3b), including participants who received both doses of study vaccine and no infection between Day 1 and Day 35 but including those who were seropositive at baseline (Day 1). As pre-specified, data are presented pooled per treatment received for participants in Phases 1/2/3a/3b only.
Number of participants with a first occurrence of COVID-19 irrespective of prior infection.
Outcome measures
| Measure |
ARCT-154
n=8492 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=7941 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants With a First Occurrence of COVID-19 Irrespective of Prior Infection
|
223 Participants
|
457 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 92Population: Intent-to-Treat (ITT) Analysis Set, which included all participants who received any dose of study vaccine. Participants were analyzed according to the vaccine to which the participant was randomly assigned. As pre-specified, data are presented for participants in the Phase 3b ITT.
Number of participants with a first occurrence of COVID-19 in participants with no evidence of prior infection.
Outcome measures
| Measure |
ARCT-154
n=8056 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phases 1, 2, 3a, 3b.
|
Placebo
n=8044 Participants
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for placebo received in Phases 1, 2, 3a, 3b.
|
Phase 3c: ARCT-154
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). Data in this arm are presented pooled for ARCT-154 vaccine received in Phase 3c.
|
Astra Zeneca COVID-19 vaccine
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c.
|
|---|---|---|---|---|
|
Number of Participants With a First Occurrence of COVID-19
|
223 Participants
|
496 Participants
|
—
|
—
|
Adverse Events
Phases 1, 2, 3a, 3b: ARCT-154 Day 1-92
Serious events: 133 serious events
Other events: 1303 other events
Deaths: 5 deaths
Phases 1, 2, 3a, 3b: Placebo Day 1-92
Serious events: 217 serious events
Other events: 1489 other events
Deaths: 16 deaths
Phases 1, 2, 3a, 3b: Placebo or ARCT-154 Day 92-End of Study (Day 394)
Serious events: 180 serious events
Other events: 1618 other events
Deaths: 12 deaths
Phases 1, 2, 3a, 3b: ARCT-154 Day 92-End of Study (Day 394)
Serious events: 176 serious events
Other events: 1374 other events
Deaths: 9 deaths
Phase 3c: ARCT-154 Day 1-92
Serious events: 22 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-92
Serious events: 35 serious events
Other events: 0 other events
Deaths: 1 deaths
Phase 3c: ARCT-154 Day 92- End of Study (Day 394)
Serious events: 64 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 3c: Astra Zeneca COVID-19 vaccine Day 92-End of Study (Day 394)
Serious events: 53 serious events
Other events: 0 other events
Deaths: 3 deaths
Phase 3c: ARCT-154 Day 1-57
Serious events: 0 serious events
Other events: 339 other events
Deaths: 0 deaths
Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-57
Serious events: 0 serious events
Other events: 304 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phases 1, 2, 3a, 3b: ARCT-154 Day 1-92
n=8807 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 1-92 in this arm are presented for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b (pooled).
|
Phases 1, 2, 3a, 3b: Placebo Day 1-92
n=8294 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 1-92 in this arm are presented for participants who initially received placebo in Phases 1, 2, 3a, 3b (pooled).
|
Phases 1, 2, 3a, 3b: Placebo or ARCT-154 Day 92-End of Study (Day 394)
n=8161 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 92- End of Study (Day 394) in this arm are presented for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b (pooled), and then placebo or ARCT-154 from Day 92-EOS.
|
Phases 1, 2, 3a, 3b: ARCT-154 Day 92-End of Study (Day 394)
n=7582 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 92- End of Study (Day 394) in this arm are presented for participants who initially received placebo in Phases 1, 2, 3a, 3b (pooled) and then ARCT-154 from Day 92-EOS.
|
Phase 3c: ARCT-154 Day 1-92
n=1186 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 1-92.
|
Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-92
n=1180 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 1-92.
|
Phase 3c: ARCT-154 Day 92- End of Study (Day 394)
n=1171 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 92- End of Study (Day 394).
|
Phase 3c: Astra Zeneca COVID-19 vaccine Day 92-End of Study (Day 394)
n=1168 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 92- End of Study (Day 394).
|
Phase 3c: ARCT-154 Day 1-57
n=1186 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 1-57.
|
Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-57
n=1180 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 1-57.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.03%
3/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.06%
5/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.13%
11/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.12%
9/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.34%
4/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Angle closure glaucoma
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Cataract
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Pterygium
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Food poisoning
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.26%
3/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastritis
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.07%
6/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.05%
4/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.07%
5/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Injection site reaction
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Pyrexia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.06%
5/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Immune system disorders
Drug hypersensitivity
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Immune system disorders
Hypersensitivity
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Immune system disorders
Type IV hypersensitivity reaction
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Appendicitis
|
0.05%
4/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.07%
6/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.11%
8/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.05%
4/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.26%
3/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
COVID-19
|
0.57%
50/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.7%
139/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.16%
13/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.22%
17/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.42%
5/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.68%
8/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.34%
4/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Cellulitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Cystitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Diarrhoea infectious
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Gastritis bacterial
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Gastroenteritis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Gastrointestinal infection
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Localised infection
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Peritonitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Pneumonia
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.06%
5/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.06%
5/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.07%
5/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.34%
4/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.60%
7/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Pneumonia acinetobacter
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Sebaceous gland infection
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Septic shock
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Sinusitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Skin infection
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Urinary tract infection
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Administration related reaction
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Foreign body in throat
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Spondylopathy traumatic
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Wound
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.05%
4/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lymphoma
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Glaucoma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
3/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Headache
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.05%
4/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.26%
3/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Renal colic
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Surgical and medical procedures
Surgery
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Deep vein thrombosis
|
0.01%
1/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Hypertension
|
0.02%
2/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
4/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Keratitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Chest pain
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Immune system disorders
Allergy to chemicals
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Infection
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Snake bite
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Eye disorder
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.26%
3/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.08%
1/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Abscess
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Laryngopharyngitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.17%
2/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Eye disorders
Blepharitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.26%
3/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.05%
4/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal polyp
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.09%
1/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Endocrine disorders
Parathyroid disorder
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Gastrointestinal polyp
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Accidental death
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Death
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Necrosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Dengue haemorrhagic fever
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Otitis media
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Tuberculosis gastrointestinal
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.02%
2/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Foreign body in mouth
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Arachnoid cyst
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Pregnancy, puerperium and perinatal conditions
Risk of future pregnancy miscarriage
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Nephritic syndrome
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.04%
3/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.03%
2/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.01%
1/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1171 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1168 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
Other adverse events
| Measure |
Phases 1, 2, 3a, 3b: ARCT-154 Day 1-92
n=8807 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 1-92 in this arm are presented for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b (pooled).
|
Phases 1, 2, 3a, 3b: Placebo Day 1-92
n=8294 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 1-92 in this arm are presented for participants who initially received placebo in Phases 1, 2, 3a, 3b (pooled).
|
Phases 1, 2, 3a, 3b: Placebo or ARCT-154 Day 92-End of Study (Day 394)
n=8161 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 µg or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series (Day 1 and Day 29) of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 92- End of Study (Day 394) in this arm are presented for participants who initially received ARCT-154 in Phases 1, 2, 3a, 3b (pooled), and then placebo or ARCT-154 from Day 92-EOS.
|
Phases 1, 2, 3a, 3b: ARCT-154 Day 92-End of Study (Day 394)
n=7582 participants at risk
This study was conducted in 3 phases (Phase 1, 2, 3a, 3b, 3c). Phase 1, 2, 3a, 3b: Participants were randomly assigned to receive up to 2 vaccination series at 28-day intervals: an initial vaccination series with vaccinations on Day 1 and Day 29 and an additional vaccination series on Day 92 and 120. Each participant received a two-dose vaccination series of ARCT-154 at a dose of 5 micrograms (µg) or a two-dose vaccination series of placebo (saline) in the first series. In the second vaccination series, participants in Phase 1 and 3b received a two-dose vaccination series with the opposite vaccine on Day 92 and 120 ("Switchover" vaccination series). Participants in Phase 2 and 3a who received 2 doses of ARCT-154 vaccine in the first vaccine series were re-randomized to receive either dose 3 of ARCT-154 on Day 92 plus placebo on Day 120 or placebo on Day 92 plus placebo on Day 120. Phase 3c: Participants were randomly assigned to a study group to receive two-dose vaccination series of ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]). In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data for Day 92- End of Study (Day 394) in this arm are presented for participants who initially received placebo in Phases 1, 2, 3a, 3b (pooled) and then ARCT-154 from Day 92-EOS.
|
Phase 3c: ARCT-154 Day 1-92
n=1186 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 1-92.
|
Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-92
n=1180 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 1-92.
|
Phase 3c: ARCT-154 Day 92- End of Study (Day 394)
n=1171 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 92- End of Study (Day 394).
|
Phase 3c: Astra Zeneca COVID-19 vaccine Day 92-End of Study (Day 394)
n=1168 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 92- End of Study (Day 394).
|
Phase 3c: ARCT-154 Day 1-57
n=1186 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover). As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for ARCT-154 received in Phase 3c from Day 1-57.
|
Phase 3c: Astra Zeneca COVID-19 vaccine Day 1-57
n=1180 participants at risk
Phase 3c: Participants were randomly assigned to a study group to receive ARCT-154 at a dose of 5 µg or approved COVID-19 vaccine comparator (Astra Zeneca's COVID-19 vaccine \[ChAdOx1 nCoV-19\]) on Day 1 and Day 29. In Phase 3c, participants received only 2 doses of their assigned treatment (no switchover) on Days 1 and 29. As pre-specified, data are presented pooled per treatment received. Data in this arm are presented pooled for Astra Zeneca COVID-19 vaccine received in Phase 3c from Day 1-57.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
1.3%
113/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.2%
96/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.6%
128/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.4%
107/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
COVID-19
|
0.64%
56/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.5%
123/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
14.7%
1199/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
13.3%
1006/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.51%
6/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.2%
14/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Influenza
|
2.3%
201/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
2.3%
188/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
7.0%
83/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
5.7%
67/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Infections and infestations
Pharyngitis
|
1.2%
106/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.3%
110/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
2.4%
29/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
2.2%
26/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
125/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.6%
132/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
2.9%
34/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
2.0%
24/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Nervous system disorders
Headache
|
3.2%
281/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
3.4%
285/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
4.6%
55/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
5.9%
70/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
128/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.7%
141/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.4%
17/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.2%
14/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.76%
67/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.1%
91/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Vascular disorders
Hypertension
|
4.0%
349/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
3.9%
323/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
3.6%
291/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
3.4%
261/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
6.6%
78/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
5.1%
60/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.84%
10/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.3%
15/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
General disorders
Fatigue
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.5%
18/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.2%
14/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.0%
12/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.76%
9/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8807 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8294 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/8161 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.00%
0/7582 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
—
0/0 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
1.1%
13/1186 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
|
0.76%
9/1180 • All-cause mortality and serious adverse events (AEs): Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394). Other (non-serious) AEs for Phases 1, 2, 3a and 3b: Day 1 to Day 92, and Day 92 to End of Study (up to approximately Day 394) and other (non-serious) AEs for Phase 3c: Day 1-57.
Safety Analysis Set: participants who received vaccine with evaluable data. As pre-specified, data were collected/reported pooled per treatment for Day 1-92\&Day 92-End of Study (EOS) for mortality\&SAEs. As pre-specified, other AEs for Phases 1,2,3a,3b were collected/reported for Day 1-92 \&Day 92-EOS and for Phase 3c Day 1-57. The different data collection periods are reported as distinct arms. AE data were not collected per actual intervention for switchover and re-randomization for 1/2/3a/3b.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place