Trial Outcomes & Findings for Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults (NCT NCT04127786)

Results Overview

RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1708 participants

Primary outcome timeframe

Day 42 (post-vaccination)

Results posted on

2026-02-10

Participant Flow

The study enrolled participants at 4 active sites in Thailand from 21 October 2019 to 23 January 2023. A total of 1708 participants were enrolled and randomized in the study. The study involves 2 phases: Primary series (Cohort 1: 3-dose pre-exposure prophylaxis \[PrEP\] regimen and Cohort 2: 1-week 2-dose PrEP regimen); and Booster Phase (Cohort 1: booster dose 1 year after first primary series vaccine injection and Cohort 2: Immunogenicity Persistence and Booster Phase Cohort 2).

The analysis contains all data in the primary series and booster phase of Cohort (C)-1 and Cohort-2.

Participant milestones

Participant milestones
Measure	Cohort-1 Group 1: VRVg-2/VRVg-2 Pediatric and adult participants received 3 intramuscular (IM) injections of Purified Vero Rabies Vaccine - Serum Free (VRVg-2) vaccine at Day 0, Day 7, and Day 28 respectively in the primary series. A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Cohort-1 Group 2: Verorab®/VRVg-2 Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively in the primary series. A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Cohort-1 Group 3: Imovax Rabies®/VRVg-2 Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively in primary series. A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Cohort-2 Group 4: VRVg-2/VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.	Cohort-2 Group 5: Verorab®/VRVg-2 Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.	Cohort-2 Group 6: Imovax Rabies®/VRVg-2 Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Primary: C-1: Day[D]0-D28; C-2:D0-D7 STARTED	607	203	200	420	139	139
Primary: C-1: Day[D]0-D28; C-2:D0-D7 Safety Analysis Set (SafAS)	607	202	200	419	139	139
Primary: C-1: Day[D]0-D28; C-2:D0-D7 Per-protocol Analysis Set (PPAS) for Day 28	519	169	160	342	120	124
Primary: C-1: Day[D]0-D28; C-2:D0-D7 COMPLETED	599	199	196	415	137	138
Primary: C-1: Day[D]0-D28; C-2:D0-D7 NOT COMPLETED	8	4	4	5	2	1
Booster:C-1:At Month(M) 12; C-2:M24-M36 STARTED	94	31	32	128	41	43
Booster:C-1:At Month(M) 12; C-2:M24-M36 SafAS	94	31	32	128	41	43
Booster:C-1:At Month(M) 12; C-2:M24-M36 COMPLETED	92	31	32	127	41	43
Booster:C-1:At Month(M) 12; C-2:M24-M36 NOT COMPLETED	2	0	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort-1 Group 1: VRVg-2/VRVg-2 Pediatric and adult participants received 3 intramuscular (IM) injections of Purified Vero Rabies Vaccine - Serum Free (VRVg-2) vaccine at Day 0, Day 7, and Day 28 respectively in the primary series. A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Cohort-1 Group 2: Verorab®/VRVg-2 Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively in the primary series. A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Cohort-1 Group 3: Imovax Rabies®/VRVg-2 Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively in primary series. A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Cohort-2 Group 4: VRVg-2/VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.	Cohort-2 Group 5: Verorab®/VRVg-2 Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.	Cohort-2 Group 6: Imovax Rabies®/VRVg-2 Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively in the primary series. A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Primary: C-1: Day[D]0-D28; C-2:D0-D7 Adverse Event	1	0	0	1	0	1
Primary: C-1: Day[D]0-D28; C-2:D0-D7 Protocol Violation	5	3	4	3	2	0
Primary: C-1: Day[D]0-D28; C-2:D0-D7 Withdrawal by Subject	0	0	0	1	0	0
Primary: C-1: Day[D]0-D28; C-2:D0-D7 Withdrawal by Parent/Guardian	2	1	0	0	0	0
Booster:C-1:At Month(M) 12; C-2:M24-M36 Withdrawal by Subject	2	0	0	1	0	0

Baseline Characteristics

Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=203 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 3: Imovax Rabies® n=200 Participants Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=420 Participants Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 Participants Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Total n=1708 Participants Total of all reporting groups
Age, Continuous	22.9 years STANDARD_DEVIATION 17.1 • n=4 Participants	22.6 years STANDARD_DEVIATION 16.1 • n=4 Participants	22.4 years STANDARD_DEVIATION 16.1 • n=8 Participants	37.4 years STANDARD_DEVIATION 11.3 • n=32 Participants	38.4 years STANDARD_DEVIATION 11.1 • n=33 Participants	37.3 years STANDARD_DEVIATION 10.9 • n=32 Participants	28.8 years STANDARD_DEVIATION 16.4 • n=230 Participants
Sex: Female, Male Female	399 Participants n=4 Participants	147 Participants n=4 Participants	122 Participants n=8 Participants	266 Participants n=32 Participants	96 Participants n=33 Participants	98 Participants n=32 Participants	1128 Participants n=230 Participants
Sex: Female, Male Male	208 Participants n=4 Participants	56 Participants n=4 Participants	78 Participants n=8 Participants	154 Participants n=32 Participants	43 Participants n=33 Participants	41 Participants n=32 Participants	580 Participants n=230 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=230 Participants
Race (NIH/OMB) Asian	607 Participants n=4 Participants	203 Participants n=4 Participants	200 Participants n=8 Participants	420 Participants n=32 Participants	139 Participants n=33 Participants	139 Participants n=32 Participants	1708 Participants n=230 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=230 Participants
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=230 Participants
Race (NIH/OMB) White	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=230 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=230 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants	0 Participants n=32 Participants	0 Participants n=33 Participants	0 Participants n=32 Participants	0 Participants n=230 Participants

PRIMARY outcome

Timeframe: Day 42 (post-vaccination)

Population: Analysis was performed on the per-protocol analysis set (PPAS) for Day 42 that included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 42. Here, 'number analyzed' = participants with available data for each specified category. Data for this outcome measure was planned to be collected and analyzed only for Primary series cohort-1 and separately for adults and pediatric participants.

RVNA titer against rabies virus was assessed using the Rapid Fluorescent Focus Inhibition test (RFFIT) assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=162 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=519 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=169 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL Pediatric (< 18 years)	100 percentage of participants Interval 95.7 to 100.0	100 percentage of participants Interval 98.6 to 100.0	100 percentage of participants Interval 95.8 to 100.0	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody (RVNA) Titer Greater Than or Equal to (>=) 0.5 IU/mL Adult (>= 18 years)	100 percentage of participants Interval 95.4 to 100.0	100 percentage of participants Interval 98.6 to 100.0	98.8 percentage of participants Interval 93.5 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=162 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=519 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=169 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Day 0	0 percentage of participants Interval 0.0 to 2.3	0 percentage of participants Interval 0.0 to 0.7	0 percentage of participants Interval 0.0 to 2.2	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Day 28	98.8 percentage of participants Interval 95.6 to 99.8	100 percentage of participants Interval 99.3 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Day 42	100 percentage of participants Interval 97.7 to 100.0	100 percentage of participants Interval 99.3 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 0 (pre-vaccination), Day 28 (post-vaccination); Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure and 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), Group 2 was equivalent to Group 5 (both groups received Verorab®), and Group 3 was equivalent to Group 6 (both groups received Imovax Rabies®), therefore it was planned to collect and present pooled data of specified Groups, and separately for adults and pediatric participants in this outcome measure.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=284 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=861 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=289 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population Pediatric (< 18 years)	100 percentage of participants Interval 95.5 to 100.0	100 percentage of participants Interval 98.6 to 100.0	100 percentage of participants Interval 95.8 to 100.0	—	—	—	—	—	—
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population Adult (>= 18 years)	96.6 percentage of participants Interval 93.0 to 98.6	98.3 percentage of participants Interval 96.9 to 99.2	98.5 percentage of participants Interval 95.7 to 99.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pooled Groups 1 and 4: Day 28 (post-vaccination) and Primary Series: Cohort-1 Group 3: Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS that included all participants who received at least 1 dose of the study with no relevant protocol deviation. Here, 'overall number of participants analyzed' signifies participants with available data for this outcome measure and 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group, and separately for adults and pediatric participants in this outcome measure. Data for this outcome measure was planned to be collected at Day 28 for Pooled Groups 1 and 4 and at Day 42 for Primary Series: Cohort-1 Group 3: Imovax Rabies® and reported as overall data for the non-inferiority analysis in this outcome measure.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=861 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=162 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis Pediatric (< 18 years)	—	100 percentage of participants Interval 98.6 to 100.0	100 percentage of participants Interval 95.7 to 100.0	—	—	—	—	—	—
Primary Series: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population (Groups 1 and 4) Versus Cohort 1: Group 3: Non-inferiority Analysis Adult (>= 18 years)	—	98.3 percentage of participants Interval 96.9 to 99.2	100 percentage of participants Interval 95.4 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28.

RVNA titer against rabies virus was assessed using the RFFIT assay method. At Baseline, Group 1 was equivalent to Group 4 (both groups received VRVg-2), therefore it was planned to collect and present pooled data of specified Group in this outcome measure.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=861 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series: Groups 1 and 4: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Pooled Population - Superiority Analysis	—	98.8 percentage of participants Interval 97.9 to 99.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS. Here, 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=162 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis Day 0	—	0 percentage of participants Interval 0.0 to 2.3	—	—	—	—	—	—	—
Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis Day 28	—	98.8 percentage of participants Interval 95.6 to 99.8	—	—	—	—	—	—	—
Primary Series Cohort 1 Group 3: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL - Non-Inferiority Analysis Day 42	—	100 percentage of participants Interval 97.7 to 100.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=162 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=519 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=169 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus Day 0	0.101 IU/mL Interval 0.1 to 0.101	0.100 IU/mL Interval 0.1 to 0.1	0.101 IU/mL Interval 0.1 to 0.102	—	—	—	—	—	—
Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus Day 28	5.13 IU/mL Interval 4.48 to 5.87	7.16 IU/mL Interval 6.66 to 7.69	4.90 IU/mL Interval 4.31 to 5.57	—	—	—	—	—	—
Primary Series Cohort 1: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus Day 42	16.4 IU/mL Interval 14.7 to 18.3	24.0 IU/mL Interval 22.4 to 25.7	20.0 IU/mL Interval 17.6 to 22.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28 that included all participants who received at least 1 dose of the study vaccine in the primary series, with no relevant protocol deviation before Day 28.

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=124 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=342 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=120 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus Day 0	0.100 IU/mL Interval 0.1 to 0.101	0.101 IU/mL Interval 0.1 to 0.101	0.101 IU/mL Interval 0.1 to 0.101	—	—	—	—	—	—
Primary Series Cohort 2: Rabies Virus Neutralizing Antibody Geometric Mean Titers (GMTs) Against Rabies Virus Day 28	3.91 IU/mL Interval 3.25 to 4.7	3.79 IU/mL Interval 3.42 to 4.2	2.92 IU/mL Interval 2.45 to 3.48	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on PPAS for Day 28.

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=124 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=342 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=120 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Day 28	96.0 percentage of participants Interval 90.8 to 98.7	97.1 percentage of participants Interval 94.7 to 98.6	98.3 percentage of participants Interval 94.1 to 99.8	—	—	—	—	—	—
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Day 0	0 percentage of participants Interval 0.0 to 2.9	0 percentage of participants Interval 0.0 to 1.1	0 percentage of participants Interval 0.0 to 3.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=162 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=519 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=169 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Day 0	0 percentage of participants Interval 0.0 to 2.3	0 percentage of participants Interval 0.0 to 0.7	0 percentage of participants Interval 0.0 to 2.2	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Day 28	100 percentage of participants Interval 97.7 to 100.0	100 percentage of participants Interval 99.3 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Day 42	100 percentage of participants Interval 97.7 to 100.0	100 percentage of participants Interval 99.3 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28.

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=124 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=342 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=120 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Day 0	0 percentage of participants Interval 0.0 to 2.9	0 percentage of participants Interval 0.0 to 1.1	0 percentage of participants Interval 0.0 to 3.0	—	—	—	—	—	—
Primary Series Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Day 28	98.4 percentage of participants Interval 94.3 to 99.8	99.7 percentage of participants Interval 98.4 to 100.0	100 percentage of participants Interval 97.0 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28 and Day 42) and pre-vaccination on Day 0.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=162 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=519 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=169 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Day 42/Day 0	163 ratio Interval 146.0 to 182.0	240 ratio Interval 224.0 to 256.0	199 ratio Interval 174.0 to 226.0	—	—	—	—	—	—
Primary Series Cohort 1: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Day 28/Day 0	51.0 ratio Interval 44.6 to 58.3	71.5 ratio Interval 66.6 to 76.8	48.7 ratio Interval 42.8 to 55.3	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28.

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post-vaccination (i.e., on Day 28) and pre-vaccination on Day 0.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=124 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=342 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=120 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers	38.9 ratio Interval 32.4 to 46.7	37.7 ratio Interval 34.0 to 41.8	29.0 ratio Interval 24.4 to 34.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 1: Day 0 (pre-vaccination), Day 28 and Day 42 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 42. Here, 'number analyzed' signifies participants with available data for each specified category.

Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=162 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=519 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=169 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 28 - Complete neutralization	99.4 percentage of participants Interval 96.6 to 100.0	100 percentage of participants Interval 99.3 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 28 - Incomplete neutralization	0.6 percentage of participants Interval 0.0 to 3.4	0 percentage of participants Interval 0.0 to 0.7	0.6 percentage of participants Interval 0.0 to 3.3	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 42 - Complete neutralization	100 percentage of participants Interval 97.7 to 100.0	100 percentage of participants Interval 99.3 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 42 - Incomplete neutralization	0 percentage of participants Interval 0.0 to 2.3	0 percentage of participants Interval 0.0 to 0.7	0.6 percentage of participants Interval 0.0 to 3.3	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 0 - Complete neutralization	1.3 percentage of participants Interval 0.2 to 4.5	0.2 percentage of participants Interval 0.0 to 1.1	0.6 percentage of participants Interval 0.0 to 3.3	—	—	—	—	—	—
Primary Series Cohort 1: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 0 - Incomplete neutralization	98.7 percentage of participants Interval 95.5 to 99.8	99.8 percentage of participants Interval 98.9 to 100.0	99.4 percentage of participants Interval 96.7 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cohort 2: Day 0 (pre-vaccination) and Day 28 (post-vaccination)

Population: Analysis was performed on the PPAS for Day 28. Here, 'number analyzed' signifies participants with available data for each specified category.

Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=124 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=342 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=120 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 0 - Complete neutralization	0 percentage of participants Interval 0.0 to 3.1	0.9 percentage of participants Interval 0.2 to 2.6	4.2 percentage of participants Interval 1.4 to 9.5	—	—	—	—	—	—
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 0 - Incomplete neutralization	100 percentage of participants Interval 96.9 to 100.0	99.1 percentage of participants Interval 97.4 to 99.8	95.8 percentage of participants Interval 90.5 to 98.6	—	—	—	—	—	—
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 28 - Complete neutralization	98.4 percentage of participants Interval 94.3 to 99.8	100 percentage of participants Interval 98.9 to 100.0	100 percentage of participants Interval 97.0 to 100.0	—	—	—	—	—	—
Primary Series Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Day 28 - Incomplete neutralization	1.6 percentage of participants Interval 0.2 to 5.7	0 percentage of participants Interval 0.0 to 1.1	0 percentage of participants Interval 0.0 to 3.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on PPAS for Booster at Month 12 that included a subset of adults who received a 3 doses regimen and received a single booster dose of VRVg-2 one year after the first vaccination of the primary series (i.e., at Month 12), with no relevant protocol deviation before Month 12 + Day 14.

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in IU/mL.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=28 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=80 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=26 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus Month 12	0.487 IU/mL Interval 0.311 to 0.764	0.679 IU/mL Interval 0.526 to 0.878	0.540 IU/mL Interval 0.344 to 0.848	—	—	—	—	—	—
Booster Phase: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus Month 12 + 14 Days	33.7 IU/mL Interval 22.6 to 50.3	56.5 IU/mL Interval 45.4 to 70.3	57.1 IU/mL Interval 42.6 to 76.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12.

RVNA titer against rabies virus was assessed using the RFFIT assay method.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=28 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=80 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=26 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Month 12 + 14 days	100 percentage of participants Interval 87.7 to 100.0	100 percentage of participants Interval 95.5 to 100.0	100 percentage of participants Interval 86.8 to 100.0	—	—	—	—	—	—
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Month 12	35.7 percentage of participants Interval 18.6 to 55.9	53.8 percentage of participants Interval 42.2 to 65.0	53.8 percentage of participants Interval 33.4 to 73.4	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12.

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=28 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=80 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=26 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ) Month 12 + 14 days	100 percentage of participants Interval 87.7 to 100.0	100 percentage of participants Interval 95.5 to 100.0	100 percentage of participants Interval 86.8 to 100.0	—	—	—	—	—	—
Booster Phase: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (LLOQ) Month 12	85.7 percentage of participants Interval 67.3 to 96.0	86.3 percentage of participants Interval 76.7 to 92.9	76.9 percentage of participants Interval 56.4 to 91.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12.

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs post vaccination (i.e., on Month 12 and Month 12 + Day 14) and pre-vaccination on Day 0, pre-booster dose on Month 12.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=28 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=80 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=26 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Month 12/Day 0	4.78 ratio Interval 3.1 to 7.37	6.79 ratio Interval 5.26 to 8.78	5.40 ratio Interval 3.44 to 8.48	—	—	—	—	—	—
Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Month 12+14 days/Day 0	331 ratio Interval 219.0 to 500.0	565 ratio Interval 454.0 to 703.0	571 ratio Interval 426.0 to 767.0	—	—	—	—	—	—
Booster Phase: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Month 12+14 days/Month 12	69.2 ratio Interval 39.6 to 121.0	83.2 ratio Interval 62.0 to 112.0	106 ratio Interval 62.7 to 178.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 12 (pre-booster dose) and Month 12 + Day 14 (post-booster dose)

Population: Analysis was performed on the PPAS for Booster at Month 12. Here, 'number analyzed' signifies participants with available data for each specified category.

Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=28 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=80 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=26 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 12 - Complete neutralization	95.7 percentage of participants Interval 78.1 to 99.9	96.1 percentage of participants Interval 89.0 to 99.2	84.0 percentage of participants Interval 63.9 to 95.5	—	—	—	—	—	—
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 12 - Incomplete neutralization	4.3 percentage of participants Interval 0.1 to 21.9	3.9 percentage of participants Interval 0.8 to 11.0	16.0 percentage of participants Interval 4.5 to 36.1	—	—	—	—	—	—
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 12 + 14 days - Complete neutralization	100 percentage of participants Interval 87.2 to 100.0	100 percentage of participants Interval 95.5 to 100.0	100 percentage of participants Interval 86.8 to 100.0	—	—	—	—	—	—
Booster Phase: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 12 + 14 days - Incomplete neutralization	0 percentage of participants Interval 0.0 to 12.8	0 percentage of participants Interval 0.0 to 4.5	0 percentage of participants Interval 0.0 to 13.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)

Population: Results are based on the PPAS for booster between Month 24 up to Month 36 that included a subset of adults who received a 1 week 2-dose regimen and a single booster dose of VRVg-2 between Month 24 and up to Month 36 after the first vaccination of the primary series with no relevant protocol deviation before Month 24 up to Month 36 + Day 14.

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTs were expressed in International units/milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=37 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=108 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=33 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus Month 24 up to Month 36	0.903 IU/mL Interval 0.603 to 1.35	0.761 IU/mL Interval 0.607 to 0.953	0.536 IU/mL Interval 0.385 to 0.747	—	—	—	—	—	—
Booster Phase Cohort 2: Rabies Virus Neutralizing Antibody (RVNA) Geometric Mean Titers (GMTs) Against Rabies Virus Month 24 up to Month 36 + 14 Days	64.7 IU/mL Interval 43.7 to 95.9	95.4 IU/mL Interval 76.7 to 119.0	89.4 IU/mL Interval 55.8 to 143.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)

Population: Results are based on the PPAS for booster between Month 24 up to Month 36.

RVNA titer against rabies virus was assessed using the RFFIT assay method. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=37 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=108 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=33 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Month 24 up to Month 36 + 14 Days	100 percentage of participants Interval 90.5 to 100.0	100 percentage of participants Interval 96.6 to 100.0	100 percentage of participants Interval 89.4 to 100.0	—	—	—	—	—	—
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.5 IU/mL Month 24 up to Month 36	64.9 percentage of participants Interval 47.5 to 79.8	62.0 percentage of participants Interval 52.2 to 71.2	51.5 percentage of participants Interval 33.5 to 69.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)

Population: Results are based on the PPAS for booster between Month 24 up to Month 36.

RVNA titer against rabies virus was assessed using the RFFIT assay method. LLOQ for the RFFIT assay was 0.2 IU/mL. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=37 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=108 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=33 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Month 24 up to Month 36	89.2 percentage of participants Interval 74.6 to 97.0	89.8 percentage of participants Interval 82.5 to 94.8	87.9 percentage of participants Interval 71.8 to 96.6	—	—	—	—	—	—
Booster Phase Cohort 2: Percentage of Participants With Rabies Virus Neutralizing Antibody Titers >=0.2 IU/mL (Lower Limit of Quantification [LLOQ]) Month 24 up to Month 36 + 14 Days	100 percentage of participants Interval 90.5 to 100.0	100 percentage of participants Interval 96.6 to 100.0	100 percentage of participants Interval 89.4 to 100.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 0 (pre-vaccination), Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)

Population: Results are based on the PPAS for booster between Month 24 up to Month 36.

RVNA titer against rabies virus was assessed using the RFFIT assay method. GMTRs were calculated as the ratio of GMTs pre-booster/pre-vaccination (Month 24 up to Month 36/Day 0); post-booster/pre-vaccination (Month 24 up to Month 36 +14 days/Day 0); post-booster/pre-booster (Month 24 up to Month 36+14 days/Month 24 up to Month 36).

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=37 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=108 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=33 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Month 24 up to Month 36/Day 0	9.03 ratio Interval 6.03 to 13.5	7.58 ratio Interval 6.06 to 9.48	5.30 ratio Interval 3.8 to 7.4	—	—	—	—	—	—
Booster Phase Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Month 24 up to Month 36 +14 days/Day 0	647 ratio Interval 437.0 to 959.0	951 ratio Interval 764.0 to 1184.0	885 ratio Interval 548.0 to 1430.0	—	—	—	—	—	—
Booster Phase Cohort 2: Geometric Mean Titer Ratio (GMTR) of Rabies Virus Neutralizing Antibody Titers Month 24 up to Month 36+14 days/Month 24 up to Month 36	71.7 ratio Interval 42.3 to 122.0	125 ratio Interval 98.1 to 160.0	167 ratio Interval 101.0 to 276.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Month 24 up to Month 36 (pre-booster dose) and Month 24 up to Month 36 + Day 14 (post-booster dose)

Population: Results are based on the PPAS for Booster between Month 24 up to Month 36. Here, 'number analyzed' signifies number of participants with available data for this outcome measure for each specified category.

Virus neutralization was defined as complete (absence of fluorescent cells) and incomplete (presence of fluorescent cells) at the participant/timepoint level at the starting dilution (1/5) of RFFIT assay. Percentage of participants with determined complete and determined incomplete virus neutralization were reported. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=37 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=108 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=33 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 24 up to Month 36- Complete neutralization	91.9 percentage of participants Interval 78.1 to 98.3	94.1 percentage of participants Interval 87.5 to 97.8	93.8 percentage of participants Interval 79.2 to 99.2	—	—	—	—	—	—
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 24 up to Month 36- Incomplete neutralization	8.1 percentage of participants Interval 1.7 to 21.9	5.9 percentage of participants Interval 2.2 to 12.5	6.3 percentage of participants Interval 0.8 to 20.8	—	—	—	—	—	—
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 24 up to Month 36 + 14 days- Complete neutralization	100 percentage of participants Interval 90.5 to 100.0	100 percentage of participants Interval 96.6 to 100.0	100 percentage of participants Interval 89.4 to 100.0	—	—	—	—	—	—
Booster Phase Cohort 2: Percentage of Participants With Determined Complete and Determined Incomplete Virus Neutralization Month 24 up to Month 36 + 14 days- Incomplete neutralization	0 percentage of participants Interval 0.0 to 9.5	0 percentage of participants Interval 0.0 to 3.4	0 percentage of participants Interval 0.0 to 10.6	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 30 minutes after any vaccination

Population: Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.

An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=200 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 Participants Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 Participants Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 Participants A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 Participants A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 Participants A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 30 minutes after any vaccination

Population: Results are based on the SafAS that included participants who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.

An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset post-vaccination. All participants were observed for 30 minutes after any vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=43 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=128 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=41 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Number of Participants With Immediate Unsolicited Adverse Events (AEs)	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 7 Days after any vaccination

Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category and "0" in the number analyzed denotes that data was not collected and analyzed for the specified category as no pediatric participants were available for analysis in the specified groups.

A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged \>= 2 years.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=200 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 Participants Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 Participants Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 Participants A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 Participants A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 Participants A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Number of Participants With Systemic Reactions Fever	4 Participants	50 Participants	11 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Systemic Reactions Vomiting	1 Participants	4 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Systemic Reactions Crying abnormal	1 Participants	8 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Systemic Reactions Drowsiness	0 Participants	4 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Systemic Reactions Appetite lost	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Systemic Reactions Irritability	0 Participants	8 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Systemic Reactions Headache	46 Participants	128 Participants	49 Participants	39 Participants	9 Participants	8 Participants	4 Participants	3 Participants	5 Participants
Number of Participants With Systemic Reactions Malaise	48 Participants	161 Participants	45 Participants	37 Participants	10 Participants	12 Participants	8 Participants	3 Participants	7 Participants
Number of Participants With Systemic Reactions Myalgia	78 Participants	249 Participants	66 Participants	78 Participants	12 Participants	29 Participants	23 Participants	9 Participants	15 Participants

SECONDARY outcome

Timeframe: Within 7 Days after any vaccination

Population: Analysis was performed on the SafAS. Here, 'number analyzed' signifies participants with available data for each specified category and "0" in the number analyzed denotes that data was not collected and analyzed for the specified category as no pediatric participants were available for analysis in the specified groups.

A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, irritability, headache, malaise and myalgia. Solicited systemic reactions were collected by different age groups: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability were collected for participants aged 12 to 23 months. Fever, Headache, Malaise and Myalgia were collected for participants aged \>= 2 years.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=43 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=128 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=41 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Number of Participants With Systemic Reactions Fever	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Booster Phase Cohort 2: Number of Participants With Systemic Reactions Headache	0 Participants	3 Participants	0 Participants	—	—	—	—	—	—
Booster Phase Cohort 2: Number of Participants With Systemic Reactions Malaise	0 Participants	5 Participants	1 Participants	—	—	—	—	—	—
Booster Phase Cohort 2: Number of Participants With Systemic Reactions Myalgia	0 Participants	10 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 7 Days after any vaccination

Population: Analysis was performed on the SafAS.

A solicited reaction (SR) was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=200 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 Participants Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 Participants Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 Participants A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 Participants A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 Participants A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Number of Participants With Solicited Injection Site Reactions Injection site tenderness/pain	106 Participants	344 Participants	95 Participants	111 Participants	30 Participants	43 Participants	44 Participants	12 Participants	17 Participants
Number of Participants With Solicited Injection Site Reactions Injection site erythema	6 Participants	24 Participants	6 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Solicited Injection Site Reactions Injection site swelling	13 Participants	14 Participants	4 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 Days after any vaccination

Population: Results are based on the SafAS.

A SR was an expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in the protocol and CRB and considered as related to vaccination. An AR was all noxious and unintended responses to a medicinal product related to any dose. Solicited injection site reactions included tenderness/pain, erythema and swelling.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=43 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=128 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=41 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions Injection site tenderness/pain	6 Participants	20 Participants	2 Participants	—	—	—	—	—	—
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions Injection site erythema	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Booster Phase Cohort 2: Number of Participants With Solicited Injection Site Reactions Injection site swelling	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 28 Days after any vaccination

Population: Analysis was performed on the safety analysis set (SafAS) that included participant who had received at least one dose of the study vaccine and were analyzed according to the actual treatment received.

An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=200 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 Participants Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 Participants Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 Participants A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 Participants A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 Participants A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Number of Participants With Unsolicited Adverse Events	40 Participants	137 Participants	45 Participants	44 Participants	18 Participants	12 Participants	13 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 28 Days after any vaccination

Population: Results are based on the SafAS.

An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset post-vaccination.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=43 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=128 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=41 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Number of Participants With Unsolicited Adverse Events	3 Participants	15 Participants	1 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 & 2 and up to Month 18 for Booster Phase, Cohort 1)

Population: Analysis was performed on SafAS.

An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=20 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 Participants Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 Participants Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 Participants A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 Participants A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 Participants A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) SAEs	5 Participants	10 Participants	3 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) AESIs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to Month 42)

Population: Results are based on the SafAS.

An SAEs was any untoward medical occurrence that at any dose resulted in death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or a medically important event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. All SAEs and AESIs occurring during the study that were related to the product administered were reported by the Investigator to the Independent Ethics Committee/Institutional Review Board. Relatedness to study vaccine was based on Investigator's discretion.

Outcome measures

Outcome measures
Measure	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=43 Participants Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-1 Group 1: VRVg-2 n=128 Participants Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=41 Participants Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.
Booster Phase Cohort 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) SAEs	1 Participants	3 Participants	0 Participants	—	—	—	—	—	—
Booster Phase Cohort 2: Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) AESIs	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

Adverse Events

Primary Series: Cohort-1 Group 1: VRVg-2

Serious events: 10 serious events

Other events: 414 other events

Deaths: 0 deaths

Primary Series: Cohort-1 Group 2: Verorab®

Serious events: 3 serious events

Other events: 121 other events

Deaths: 0 deaths

Primary Series: Cohort-1 Group 3: Imovax Rabies®

Serious events: 5 serious events

Other events: 128 other events

Deaths: 0 deaths

Primary Series: Cohort-2 Group 4: VRVg-2

Serious events: 2 serious events

Other events: 130 other events

Deaths: 0 deaths

Primary Series: Cohort-2 Group 5: Verorab®

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Primary Series: Cohort-2 Group 6: Imovax Rabies®

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2)

Serious events: 2 serious events

Other events: 48 other events

Deaths: 0 deaths

Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed)

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2)

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 participants at risk Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 participants at risk Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 3: Imovax Rabies® n=200 participants at risk Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 participants at risk Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 participants at risk Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 participants at risk Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 participants at risk A subset of adult participants who received 3 IM injections of VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 participants at risk A subset of adult participants who received 3 IM injections of Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 participants at risk A subset of adult participants who received 3 IM injections of Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) n=128 participants at risk A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection ofVRVg-2 in the booster phase between Month 24 up to Month 36.	Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) n=41 participants at risk A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.	Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) n=43 participants at risk A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
Gastrointestinal disorders Abdominal Pain	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/202 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Immune system disorders Food Allergy	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/202 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Bronchitis	0.16% 1/607 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/200 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Croup Infectious	0.16% 1/607 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Dengue Fever	0.16% 1/607 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Gastroenteritis	0.16% 1/607 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Infectious Mononucleosis	0.16% 1/607 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Influenza	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.78% 1/128 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Postoperative Wound Infection	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.24% 1/419 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Rhinovirus Infection	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/202 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Septic Shock	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.78% 1/128 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Injury, poisoning and procedural complications Exposure To Communicable Disease	0.66% 4/607 • Number of events 4 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Injury, poisoning and procedural complications Intentional Overdose	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/200 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Injury, poisoning and procedural complications Keratorhexis	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/200 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Injury, poisoning and procedural complications Ligament Injury	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/200 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Injury, poisoning and procedural complications Multiple Fractures	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.24% 1/419 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.24% 1/419 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	3.1% 1/32 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Of The Cervix	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.78% 1/128 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.72% 1/139 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	2.3% 1/43 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Nervous system disorders Headache	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.78% 1/128 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Nervous system disorders Hemiplegia	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	1.1% 1/94 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	1.1% 1/94 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Pregnancy, puerperium and perinatal conditions Imminent Abortion	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.50% 1/200 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Reproductive system and breast disorders Uterine Polyp	0.00% 0/607 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	2.3% 1/43 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.16% 1/607 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/202 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/200 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/419 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.

Other adverse events

Other adverse events
Measure	Primary Series: Cohort-1 Group 1: VRVg-2 n=607 participants at risk Pediatric and adult participants received 3 IM injections of VRVg-2 vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 2: Verorab® n=202 participants at risk Pediatric and adult participants received 3 IM injections of Verorab® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-1 Group 3: Imovax Rabies® n=200 participants at risk Pediatric and adult participants received 3 IM injections of Imovax Rabies® vaccine at Day 0, Day 7, and Day 28 respectively.	Primary Series: Cohort-2 Group 4: VRVg-2 n=419 participants at risk Adult participants received 2 IM injections of VRVg-2 vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 5: Verorab® n=139 participants at risk Adult participants received 2 IM injections of Verorab® vaccine at Day 0, and Day 7 respectively.	Primary Series: Cohort-2 Group 6: Imovax Rabies® n=139 participants at risk Adult participants received 2 IM injections of Imovax Rabies® vaccine at Day 0, and Day 7 respectively.	Booster Phase: Cohort-1 Group 1: VRVg-2 (Primed With VRVg-2) n=94 participants at risk A subset of adult participants who received 3 IM injections of VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 2: VRVg-2 (Verorab® Primed) n=31 participants at risk A subset of adult participants who received 3 IM injections of Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-1 Group 3: VRVg-2 (Imovax Rabies® Primed) n=32 participants at risk A subset of adult participants who received 3 IM injections of Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase at Month 12.	Booster Phase: Cohort-2 Group 4: VRVg-2 (Primed With VRVg-2) n=128 participants at risk A subset of adult participants who received VRVg-2 vaccination in primary series and completed the follow-up period received a booster injection ofVRVg-2 in the booster phase between Month 24 up to Month 36.	Booster Phase: Cohort-2 Group 5: VRVg-2 (Verorab® Primed) n=41 participants at risk A subset of adult participants who received Verorab® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.	Booster Phase:Cohort-2 Group 6: VRVg-2 (Imovax Rabies® Primed) n=43 participants at risk A subset of adult participants who received Imovax Rabies® vaccination in primary series and completed the follow-up period received a booster injection of VRVg-2 in the booster phase between Month 24 up to Month 36.
General disorders Injection Site Pain	56.7% 344/607 • Number of events 655 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	47.0% 95/202 • Number of events 158 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	53.0% 106/200 • Number of events 191 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	26.5% 111/419 • Number of events 167 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	21.6% 30/139 • Number of events 41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	30.9% 43/139 • Number of events 63 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	46.8% 44/94 • Number of events 44 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	38.7% 12/31 • Number of events 12 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	53.1% 17/32 • Number of events 17 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	15.6% 20/128 • Number of events 20 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	4.9% 2/41 • Number of events 2 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	14.0% 6/43 • Number of events 6 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
General disorders Injection Site Swelling	2.3% 14/607 • Number of events 19 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	2.0% 4/202 • Number of events 4 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	6.5% 13/200 • Number of events 18 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.24% 1/419 • Number of events 2 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.72% 1/139 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
General disorders Malaise	26.5% 161/607 • Number of events 229 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	22.3% 45/202 • Number of events 57 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	24.0% 48/200 • Number of events 79 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	8.8% 37/419 • Number of events 43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	7.2% 10/139 • Number of events 14 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	8.6% 12/139 • Number of events 16 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	8.5% 8/94 • Number of events 8 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	9.7% 3/31 • Number of events 3 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	21.9% 7/32 • Number of events 7 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	3.9% 5/128 • Number of events 5 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	2.4% 1/41 • Number of events 1 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
General disorders Pyrexia	8.4% 51/607 • Number of events 54 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	5.9% 12/202 • Number of events 12 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	2.5% 5/200 • Number of events 5 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.72% 3/419 • Number of events 3 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Infections and infestations Nasopharyngitis	4.4% 27/607 • Number of events 27 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	4.5% 9/202 • Number of events 9 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	6.0% 12/200 • Number of events 14 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.72% 3/419 • Number of events 3 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/139 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/94 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/31 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/32 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/128 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Musculoskeletal and connective tissue disorders Myalgia	41.0% 249/607 • Number of events 405 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	33.2% 67/202 • Number of events 103 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	39.5% 79/200 • Number of events 135 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	18.6% 78/419 • Number of events 103 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	8.6% 12/139 • Number of events 17 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	21.6% 30/139 • Number of events 38 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	25.5% 24/94 • Number of events 24 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	29.0% 9/31 • Number of events 9 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	46.9% 15/32 • Number of events 15 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	7.8% 10/128 • Number of events 10 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.
Nervous system disorders Headache	21.4% 130/607 • Number of events 178 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	24.8% 50/202 • Number of events 66 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	23.5% 47/200 • Number of events 62 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	9.5% 40/419 • Number of events 46 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	7.2% 10/139 • Number of events 14 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	5.8% 8/139 • Number of events 9 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	4.3% 4/94 • Number of events 4 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	9.7% 3/31 • Number of events 3 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	21.9% 7/32 • Number of events 7 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	2.3% 3/128 • Number of events 3 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/41 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.	0.00% 0/43 • From Baseline (Day 0) up to 6 months after last vaccination (i.e., up to 7 months for Primary Series Cohorts 1 and 2 and up to Month 18 for Booster Phase Cohort 1, and up to Month 42 for Booster Phase Cohort 2). SafAS. SR: expected AR observed and reported under conditions (nature and onset) pre-listed (i.e., solicited) in protocol and CRB. Unsolicited AE: observed AE that did not fulfill conditions pre-listed (i.e., solicited) in the CRB in terms of diagnosis and/or onset post-vaccination. In the AE section, SR fever is reported as pyrexia. AE data is based on the SafAS.

Additional Information

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