Trial Outcomes & Findings for Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older (NCT NCT04798027)

Last Updated: 2025-09-11

Results Overview

AE: any untoward medical occurrence in clinical investigation participant administered medicinal product \& which did not have any causal relationship with the treatment. Unsolicited AE: observed AE that did not fulfill conditions prelisted in case report form (CRF) in terms of diagnosis \&/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, \& any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in CRF. Reported AEs were presented as pre-specified in protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

182 participants

Primary outcome timeframe

Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Results posted on

2025-09-11

Participant Flow

The study was conducted at 17 active sites in 4 countries between 12 Mar 2021 and 27 Jun 2022. Study consisted of 2 cohorts: Sentinel Cohort and Full Enrollment Cohort (FEC). For analysis purpose, Baseline, safety and outcome measure data was planned to be collected, analyzed and reported for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Participants (aged 18-49 years) in Sentinel Cohort received two vaccinations, 21 days apart. FEC participants were stratified into 2 age groups: younger adult group (18-49 years) and the older adult group (greater than or equal to \[\>=\] 50 years). FEC Cohort 1 participants received a single injection of study vaccine or placebo, while participants in Cohort 2 received two vaccinations (21 days apart). A total of 182 participants were enrolled, of which 180 were vaccinated in the study.

Participant milestones

Participant milestones
Measure	Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low Dose Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Sentinel Cohort: SARS-CoV-2 Vaccine Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	FEC Cohort 1: SARS-CoV-2 Vaccine Low Dose Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	FEC Cohort 1: Placebo Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	FEC Cohort 2: SARS-CoV-2 Vaccine Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	FEC Cohort 2: Placebo Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.
Overall Study STARTED	10	25	10	27	26	13	28	29	14
Overall Study Vaccinated on Day 1	10	25	10	27	25	13	28	28	14
Overall Study Vaccinated on Day 22	10	24	10	0	0	0	19	19	9
Overall Study Safety Analysis Set (SafAS)	18	17	10	36	34	18	19	19	9
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	10	25	10	27	26	13	28	29	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Sentinel Cohort: SARS-CoV-2 Vaccine Ultra Low Dose Participants received two intramuscular (IM) injections of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Sentinel Cohort: SARS-CoV-2 Vaccine Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	Sentinel Cohort: SARS-CoV-2 Vaccine Medium Dose Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	FEC Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	FEC Cohort 1: SARS-CoV-2 Vaccine Low Dose Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	FEC Cohort 1: Placebo Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	FEC Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	FEC Cohort 2: SARS-CoV-2 Vaccine Low Dose Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	FEC Cohort 2: Placebo Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.
Overall Study Protocol Violation	0	0	0	0	1	0	0	1	0
Overall Study Withdrawal by Subject	1	0	1	1	1	1	3	2	2
Overall Study Lost to Follow-up	1	3	0	0	0	1	0	0	1
Overall Study Withdrawal by Sponsor	8	22	9	26	24	11	25	26	11

Baseline Characteristics

Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=27 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=26 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=13 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=38 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=54 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=14 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Total n=182 Participants Total of all reporting groups
Age, Continuous	44.15 years STANDARD_DEVIATION 16.19 • n=5 Participants	41.96 years STANDARD_DEVIATION 17.05 • n=7 Participants	39.77 years STANDARD_DEVIATION 14.96 • n=5 Participants	36.21 years STANDARD_DEVIATION 13.00 • n=4 Participants	34.96 years STANDARD_DEVIATION 13.22 • n=21 Participants	31.00 years STANDARD_DEVIATION 8.94 • n=10 Participants	38.79 years STANDARD_DEVIATION 16.24 • n=115 Participants	38.01 years STANDARD_DEVIATION 14.68 • n=24 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants	25 Participants n=21 Participants	3 Participants n=10 Participants	6 Participants n=115 Participants	77 Participants n=24 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants	29 Participants n=21 Participants	7 Participants n=10 Participants	8 Participants n=115 Participants	105 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants	7 Participants n=21 Participants	10 Participants n=10 Participants	3 Participants n=115 Participants	45 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants	0 Participants n=10 Participants	4 Participants n=115 Participants	16 Participants n=24 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	18 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants	34 Participants n=21 Participants	0 Participants n=10 Participants	5 Participants n=115 Participants	113 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Population: SafAS: participants who received at least one injection of study vaccine were analyzed by the intervention they actually received. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=37 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=34 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) Post Any vaccination	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) Post vaccination 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs) Post vaccination 2	0 Participants	0 Participants	—	—	—	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Population: SafAS population. Here, "overall number of participants analyzed" = participants with available data for this outcome measure (OM). Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.

Solicited reaction (SR): expected adverse reaction (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF and considered as related to product administered. Solicited injection site reactions included pain, erythema, \& swelling. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=33 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Number of Participants With Solicited Injection Site Reactions Pain Post-any vaccination	10 Participants	2 Participants	28 Participants	28 Participants	5 Participants	33 Participants	33 Participants
Number of Participants With Solicited Injection Site Reactions Pain Post-vaccination 1	10 Participants	1 Participants	28 Participants	28 Participants	5 Participants	29 Participants	32 Participants
Number of Participants With Solicited Injection Site Reactions Pain Post-vaccination 2	10 Participants	2 Participants	—	—	—	28 Participants	32 Participants
Number of Participants With Solicited Injection Site Reactions Erythema Post-any vaccination	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	4 Participants	5 Participants
Number of Participants With Solicited Injection Site Reactions Erythema Post-vaccination 1	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	3 Participants	5 Participants
Number of Participants With Solicited Injection Site Reactions Erythema Post-vaccination 2	0 Participants	0 Participants	—	—	—	2 Participants	4 Participants
Number of Participants With Solicited Injection Site Reactions Swelling Post-any vaccination	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	6 Participants	4 Participants
Number of Participants With Solicited Injection Site Reactions Swelling Post-vaccination 1	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With Solicited Injection Site Reactions Swelling Post-vaccination 2	1 Participants	0 Participants	—	—	—	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 7 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Population: SafAS population. Here, "overall number of participants analyzed" = participants with available data for this OM. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.

SR was an expected adverse reaction (sign or symptom) observed \& reported under conditions (nature \& onset) prelisted (i.e., solicited) in CRF \& considered as related to product administered. Solicited systemic reactions included fever, headache, malaise, myalgia, arthralgia \& chills. Reported AEs for each arm were presented as pre-specified in study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=33 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Number of Participants With Solicited Systemic Reactions Fever Post-any vaccination	10 Participants	0 Participants	5 Participants	8 Participants	1 Participants	9 Participants	16 Participants
Number of Participants With Solicited Systemic Reactions Fever Post-vaccination 1	10 Participants	0 Participants	5 Participants	8 Participants	1 Participants	6 Participants	11 Participants
Number of Participants With Solicited Systemic Reactions Fever Post-vaccination 2	8 Participants	0 Participants	—	—	—	7 Participants	12 Participants
Number of Participants With Solicited Systemic Reactions Headache Post-any vaccination	10 Participants	5 Participants	17 Participants	17 Participants	6 Participants	26 Participants	31 Participants
Number of Participants With Solicited Systemic Reactions Headache Post-vaccination 1	9 Participants	3 Participants	17 Participants	17 Participants	6 Participants	22 Participants	27 Participants
Number of Participants With Solicited Systemic Reactions Headache Post-vaccination 2	7 Participants	3 Participants	—	—	—	21 Participants	27 Participants
Number of Participants With Solicited Systemic Reactions Malaise Post-any vaccination	10 Participants	2 Participants	21 Participants	21 Participants	5 Participants	28 Participants	31 Participants
Number of Participants With Solicited Systemic Reactions Malaise Post-vaccination 1	9 Participants	2 Participants	21 Participants	21 Participants	5 Participants	25 Participants	28 Participants
Number of Participants With Solicited Systemic Reactions Malaise Post-vaccination 2	9 Participants	2 Participants	—	—	—	22 Participants	28 Participants
Number of Participants With Solicited Systemic Reactions Myalgia Post-any vaccination	8 Participants	2 Participants	20 Participants	23 Participants	4 Participants	28 Participants	28 Participants
Number of Participants With Solicited Systemic Reactions Myalgia Post-vaccination 1	8 Participants	2 Participants	20 Participants	23 Participants	4 Participants	23 Participants	24 Participants
Number of Participants With Solicited Systemic Reactions Myalgia Post-vaccination 2	7 Participants	2 Participants	—	—	—	22 Participants	25 Participants
Number of Participants With Solicited Systemic Reactions Arthralgia Post-any vaccination	10 Participants	2 Participants	7 Participants	13 Participants	2 Participants	20 Participants	23 Participants
Number of Participants With Solicited Systemic Reactions Arthralgia Post-vaccination 1	5 Participants	1 Participants	7 Participants	13 Participants	2 Participants	11 Participants	18 Participants
Number of Participants With Solicited Systemic Reactions Arthralgia Post-vaccination 2	7 Participants	2 Participants	—	—	—	17 Participants	19 Participants
Number of Participants With Solicited Systemic Reactions Chills Post-any vaccination	9 Participants	1 Participants	14 Participants	17 Participants	4 Participants	20 Participants	29 Participants
Number of Participants With Solicited Systemic Reactions Chills Post-vaccination 1	8 Participants	0 Participants	14 Participants	17 Participants	4 Participants	15 Participants	23 Participants
Number of Participants With Solicited Systemic Reactions Chills Post-vaccination 2	7 Participants	1 Participants	—	—	—	17 Participants	25 Participants

PRIMARY outcome

Timeframe: Within 21 days after any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])

Population: Analyzed on SafAS population. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol. In the data table, '0' in number analyzed field denotes that no participants were available for assessment for specified Group as no one in that group received vaccination 2.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=37 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=34 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Number of Participants With Unsolicited Adverse Events Post Any vaccination	5 Participants	3 Participants	17 Participants	4 Participants	8 Participants	10 Participants	15 Participants
Number of Participants With Unsolicited Adverse Events Post vaccination 1	5 Participants	2 Participants	17 Participants	4 Participants	8 Participants	10 Participants	10 Participants
Number of Participants With Unsolicited Adverse Events Post vaccination 2	2 Participants	1 Participants	—	—	—	5 Participants	10 Participants

PRIMARY outcome

Timeframe: From Day 1 until 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups)

Population: Analysis was performed on SafAS population. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled. One ultra-low dose Sentinel Cohort participant who was supposed to receive 2 doses received only 1 \& was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.

SAEs: any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. AESIs: event for which ongoing monitoring \& rapid communication by investigator to the sponsor was done. MAAE was a new onset or worsening of a condition that prompted participant or participant's parent/legally acceptable representative to seek unplanned medical advice at physician's office or emergency department. Reported AEs for each arm were presented as pre-specified in study protocol.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=37 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=34 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) MAAEs	3 Participants	2 Participants	6 Participants	2 Participants	1 Participants	6 Participants	6 Participants
Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) SAEs	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Reporting Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs) AESI	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 up to up to 8 days post last vaccination (i.e., up to Day 9 for Cohort 1 groups; up to Day 30 for Cohort 2 groups)

Population: SafAS. "Overall number of participants analyzed" = participants with available data for this OM. Data were collected \& analyzed for the combined population in which same dose-level groups in Sentinel Cohort and FEC were pooled.

Laboratory tests: hemoglobin (male \& female), above \& below normal white blood cell, lymphocytes, neutrophils \& eosinophils, platelet count, creatinine \& blood urea nitrogen, hyponatremia \& hypernatremia, hyperkalemia \& hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \[LFT\], bilirubin (normal LFT), prothrombin \& partial thromboplastin time (seconds), Urine: protein, glucose \& blood. US FDA "Toxicity Grading Scale for Healthy Adults \& Adolescent Volunteers" was used for grading; Grade 1=mild, Grade 2=moderate \& Grade 3=severe. In the data table, 'number analyzed'=participants with available data for each specified category \& '0'=none of participants were available for assessment for specified Group.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=35 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=33 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=33 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Creatinine: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyperglycemia: Grade 2	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyperglycemia: Grade 1	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypoproteinemia: Grade 1	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyperglycemia: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hemoglobin (Female): Grade 1	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hemoglobin (Female): Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hemoglobin (Female): Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hemoglobin (Male): Grade 1	1 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hemoglobin (Male): Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hemoglobin (Male): Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Above normal white blood cell: Grade 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Above normal white blood cell: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Above normal white blood cell: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Below normal white blood cell: Grade 1	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Below normal white blood cell: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Below normal white blood cell: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Platelets Decreased: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Platelets Decreased: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Platelets Decreased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Neutrophils Decreased: Grade 1	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	6 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Neutrophils Decreased: Grade 2	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Neutrophils Decreased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Lymphocytes Decreased: Grade 1	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Lymphocytes Decreased: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Lymphocytes Decreased: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Eosinophils: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Eosinophils: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Absolute Eosinophils: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyponatremia: Grade 1	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyponatremia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyponatremia: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypernatremia: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypernatremia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypernatremia: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyperkalemia: Grade 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyperkalemia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hyperkalemia: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypokalemia: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypokalemia: Grade 2	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypokalemia: Grade 3	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Blood Urea Nitrogen: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Blood Urea Nitrogen: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Blood Urea Nitrogen: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Creatinine: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Creatinine: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Bilirubin - with normal in LFT: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypoproteinemia: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Bilirubin - with normal in LFT: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Prothrombin time: Grade 1	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Prothrombin time: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Prothrombin time: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Partial thromboplastin time: Grade 1	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	3 Participants	2 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Partial thromboplastin time: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Partial thromboplastin time: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - glucose: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - glucose: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - glucose: Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - protein: Grade 1	1 Participants	1 Participants	3 Participants	5 Participants	2 Participants	1 Participants	4 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - protein: Grade 2	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - protein: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - blood: Grade 1	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - blood: Grade 2	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Urine - blood: Grade 3	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Hypoproteinemia: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Alanine aminotransferase: Grade 1	2 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Alanine aminotransferase: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Alanine aminotransferase: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Aspartate aminotransferase: Grade 1	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Aspartate aminotransferase: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Aspartate aminotransferase: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Alkaline phosphate: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Alkaline phosphate: Grade 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Alkaline phosphate: Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Bilirubin - with any increase in LFT: Grade 1	0 Participants	—	0 Participants	—	0 Participants	—	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Bilirubin - with any increase in LFT: Grade 2	0 Participants	—	0 Participants	—	0 Participants	—	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Bilirubin - with any increase in LFT: Grade 3	0 Participants	—	0 Participants	—	0 Participants	—	0 Participants
Number of Participants With Laboratory Test Results Based on US Food and Drug Administration (FDA) Toxicity Grading Guidance Bilirubin - with normal in LFT: Grade 1	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination)

Population: Analyzed on modified full analysis set (mFAS) population that included all participants who received at least one injection of study intervention, analyzed according to the intervention they actually received, and excludes participants with positive pseudovirus neutralization test results against SARS-CoV-2 D614G variant at Baseline (Day 1). Here, "overall number of participants analyzed" signifies participants with available data for this OM.

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=34 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=28 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=16 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 1	5.00 titer 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	5.00 titer 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	5.00 titer 95% confidence interval (CI) was not computable as the standard deviation (SD) of the sample was 0, since all participants had the same value.	5.00 titer 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	5.00 titer 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	5.00 titer 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	5.00 titer 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC+ Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=31 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=16 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 22	68.2 titer Interval 29.0 to 160.0	12.8 titer Interval 2.52 to 65.1	24.0 titer Interval 15.3 to 37.6	29.7 titer Interval 14.8 to 59.6	6.66 titer Interval 3.61 to 12.3	35.2 titer Interval 21.0 to 59.0	27.7 titer Interval 16.4 to 46.9

PRIMARY outcome

Timeframe: Day 36 (post-vaccination)

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=25 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=18 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=13 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=29 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine at Day 36	416 titer Interval 303.0 to 570.0	11.6 titer Interval 2.43 to 55.5	13.6 titer Interval 8.88 to 20.9	30.1 titer Interval 15.5 to 58.6	6.48 titer Interval 3.68 to 11.4	174 titer Interval 111.0 to 273.0	223 titer Interval 147.0 to 336.0

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=31 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=15 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22	13.6 ratio Interval 5.79 to 32.1	1.32 ratio Interval 0.682 to 2.57	4.80 ratio Interval 3.07 to 7.52	5.93 ratio Interval 2.95 to 11.9	1.36 ratio Interval 0.704 to 2.62	7.05 ratio Interval 4.21 to 11.8	5.55 ratio Interval 3.28 to 9.37

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=18 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=12 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=29 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36	83.1 ratio Interval 60.7 to 114.0	1.20 ratio Interval 0.777 to 1.86	2.84 ratio Interval 1.83 to 4.4	6.03 ratio Interval 3.1 to 11.7	1.32 ratio Interval 0.714 to 2.46	34.9 ratio Interval 22.3 to 54.6	44.6 ratio Interval 29.5 to 67.3

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=31 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=15 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 >=2-fold rise	100 percentage of participants Interval 69.2 to 100.0	12.5 percentage of participants Interval 0.3 to 52.7	77.4 percentage of participants Interval 58.9 to 90.4	66.7 percentage of participants Interval 44.7 to 84.4	6.7 percentage of participants Interval 0.2 to 31.9	81.3 percentage of participants Interval 63.6 to 92.8	74.2 percentage of participants Interval 55.4 to 88.1
Percentage of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22 >=4-fold rise	100 percentage of participants Interval 69.2 to 100.0	12.5 percentage of participants Interval 0.3 to 52.7	58.1 percentage of participants Interval 39.1 to 75.5	58.3 percentage of participants Interval 36.6 to 77.9	6.7 percentage of participants Interval 0.2 to 31.9	71.9 percentage of participants Interval 53.3 to 86.3	54.8 percentage of participants Interval 36.0 to 72.7

PRIMARY outcome

Timeframe: Day 1 (pre-vaccination) and Day 36 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=18 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=12 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=29 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 >=2-fold rise	100 percentage of participants Interval 69.2 to 100.0	12.5 percentage of participants Interval 0.3 to 52.7	58.3 percentage of participants Interval 36.6 to 77.9	77.8 percentage of participants Interval 52.4 to 93.6	8.3 percentage of participants Interval 0.2 to 38.5	96.6 percentage of participants Interval 82.2 to 99.9	100 percentage of participants Interval 88.8 to 100.0
Percentage of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36 >=4-fold rise	100 percentage of participants Interval 69.2 to 100.0	12.5 percentage of participants Interval 0.3 to 52.7	45.8 percentage of participants Interval 25.6 to 67.2	66.7 percentage of participants Interval 41.0 to 86.7	8.3 percentage of participants Interval 0.2 to 38.5	96.6 percentage of participants Interval 82.2 to 99.9	100 percentage of participants Interval 88.8 to 100.0

PRIMARY outcome

Timeframe: Day 22 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=31 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=15 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22	100 percentage of participants Interval 69.2 to 100.0	12.5 percentage of participants Interval 0.3 to 52.7	77.4 percentage of participants Interval 58.9 to 90.4	66.7 percentage of participants Interval 44.7 to 84.4	6.7 percentage of participants Interval 0.2 to 31.9	81.3 percentage of participants Interval 63.6 to 92.8	74.2 percentage of participants Interval 55.4 to 88.1

PRIMARY outcome

Timeframe: Day 36 (post-vaccination)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Seroconversion was defined as participants with a Baseline (Day 1) titer values below LLOQ with a detectable neutralization antibody titer above assay LLOQ post injection (at Day 36). LLOQ of the neutralization assay was a titer of 10.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=8 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=24 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=18 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=12 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=29 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=31 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36	100 percentage of participants Interval 69.2 to 100.0	12.5 percentage of participants Interval 0.3 to 52.7	58.3 percentage of participants Interval 36.6 to 77.9	77.8 percentage of participants Interval 52.4 to 93.6	8.3 percentage of participants Interval 0.2 to 38.5	96.6 percentage of participants Interval 82.2 to 99.9	100 percentage of participants Interval 88.8 to 100.0

SECONDARY outcome

Timeframe: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 91 (only for Cohort 1), Day 112 (only for Cohort 2), Day 181 (only for Cohort 1), and Day 202 (only for Cohort 2)

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in specified Groups for the specified time point.

GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in ELISA unit/mL (ELU/mL). Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=34 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=26 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=16 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 1	10.3 ELU/mL Interval 8.52 to 12.4	14.4 ELU/mL Interval 7.08 to 29.4	10.8 ELU/mL Interval 9.08 to 12.7	10.8 ELU/mL Interval 8.84 to 13.1	9.45 ELU/mL 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	10.1 ELU/mL Interval 8.78 to 11.7	10.5 ELU/mL Interval 8.93 to 12.3
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 22	1618 ELU/mL Interval 984.0 to 2660.0	34.5 ELU/mL Interval 5.22 to 228.0	239 ELU/mL Interval 153.0 to 375.0	372 ELU/mL Interval 192.0 to 723.0	13.2 ELU/mL Interval 7.84 to 22.4	448 ELU/mL Interval 249.0 to 805.0	476 ELU/mL Interval 279.0 to 812.0
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 36	10952 ELU/mL Interval 7252.0 to 16540.0	34.4 ELU/mL Interval 5.31 to 223.0	188 ELU/mL Interval 110.0 to 319.0	310 ELU/mL Interval 165.0 to 582.0	14.1 ELU/mL Interval 7.52 to 26.3	3618 ELU/mL Interval 2431.0 to 5382.0	4903 ELU/mL Interval 3326.0 to 7228.0
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 91	—	—	185 ELU/mL Interval 36.4 to 936.0	1122 ELU/mL Interval 117.0 to 10789.0	31.2 ELU/mL 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	—	—
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 112	2782 ELU/mL Interval 1138.0 to 6799.0	96.3 ELU/mL Interval 6.61 to 1402.0	—	—	—	4548 ELU/mL Interval 1090.0 to 18981.0	1435 ELU/mL Interval 696.0 to 2962.0
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 181	—	—	62.8 ELU/mL	23251 ELU/mL	—	—	—
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 91, 112, 181, and 202 Day 202	—	17316 ELU/mL	—	—	—	384 ELU/mL	1209 ELU/mL Interval 344.0 to 4257.0

SECONDARY outcome

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.

Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=31 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=22 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=15 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 91/Day 1	—	—	26.8 ratio Interval 4.8 to 150.0	135 ratio Interval 9.27 to 1971.0	2.83 ratio 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	—	—
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 112/Day 1	271 ratio Interval 110.0 to 670.0	5.40 ratio Interval 0.445 to 65.5	—	—	—	481 ratio Interval 115.0 to 2009.0	131 ratio Interval 61.0 to 282.0
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 22/Day 1	158 ratio Interval 93.7 to 265.0	2.39 ratio Interval 0.626 to 9.13	22.5 ratio Interval 13.9 to 36.2	36.7 ratio Interval 17.5 to 76.9	1.28 ratio Interval 0.757 to 2.15	44.2 ratio Interval 24.4 to 80.0	45.3 ratio Interval 26.6 to 77.3
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 36/Day 1	1067 ratio Interval 712.0 to 1601.0	2.38 ratio Interval 0.645 to 8.81	19.5 ratio Interval 11.1 to 34.1	30.2 ratio Interval 14.6 to 62.7	1.34 ratio Interval 0.706 to 2.53	354 ratio Interval 228.0 to 551.0	466 ratio Interval 318.0 to 682.0
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 181/Day 1	—	—	6.65 ratio	2460 ratio	—	—	—
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 202/Day 1	—	125 ratio	—	—	—	40.6 ratio	101 ratio Interval 25.9 to 392.0

SECONDARY outcome

Population: Analyzed on mFAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Groups for the specified time point.

Binding antibody titers were evaluated by ELISA. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1, Day 36/Day 1, Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=31 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=22 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=15 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=32 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 22/Day 1: >=2-fold rise	100 percentage of participants Interval 69.2 to 100.0	22.2 percentage of participants Interval 2.8 to 60.0	100 percentage of participants Interval 88.8 to 100.0	100 percentage of participants Interval 84.6 to 100.0	6.7 percentage of participants Interval 0.2 to 31.9	93.8 percentage of participants Interval 79.2 to 99.2	96.9 percentage of participants Interval 83.8 to 99.9
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 22/Day 1: >=4-fold rise	100 percentage of participants Interval 69.2 to 100.0	22.2 percentage of participants Interval 2.8 to 60.0	90.3 percentage of participants Interval 74.2 to 98.0	86.4 percentage of participants Interval 65.1 to 97.1	6.7 percentage of participants Interval 0.2 to 31.9	90.6 percentage of participants Interval 75.0 to 98.0	93.8 percentage of participants Interval 79.2 to 99.2
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 36/Day 1: >=2-fold rise	100 percentage of participants Interval 69.2 to 100.0	22.2 percentage of participants Interval 2.8 to 60.0	95.8 percentage of participants Interval 78.9 to 99.9	100 percentage of participants Interval 81.5 to 100.0	8.3 percentage of participants Interval 0.2 to 38.5	100 percentage of participants Interval 88.1 to 100.0	100 percentage of participants Interval 88.8 to 100.0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 36/Day 1: >=4-fold rise	100 percentage of participants Interval 69.2 to 100.0	22.2 percentage of participants Interval 2.8 to 60.0	87.5 percentage of participants Interval 67.6 to 97.3	88.9 percentage of participants Interval 65.3 to 98.6	8.3 percentage of participants Interval 0.2 to 38.5	100 percentage of participants Interval 88.1 to 100.0	100 percentage of participants Interval 88.8 to 100.0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 91/Day 1: >=2-fold rise	—	—	85.7 percentage of participants Interval 42.1 to 99.6	100 percentage of participants Interval 59.0 to 100.0	25.0 percentage of participants Interval 0.6 to 80.6	—	—
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 91/Day 1: >=4-fold rise	—	—	85.7 percentage of participants Interval 42.1 to 99.6	100 percentage of participants Interval 59.0 to 100.0	25.0 percentage of participants Interval 0.6 to 80.6	—	—
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 112/Day 1: >=2-fold rise	100 percentage of participants Interval 69.2 to 100.0	50.0 percentage of participants Interval 11.8 to 88.2	—	—	—	100 percentage of participants Interval 78.2 to 100.0	100 percentage of participants Interval 85.2 to 100.0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 112/Day 1: >=4-fold rise	100 percentage of participants Interval 69.2 to 100.0	50.0 percentage of participants Interval 11.8 to 88.2	—	—	—	100 percentage of participants Interval 78.2 to 100.0	100 percentage of participants Interval 85.2 to 100.0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 181/Day 1: >=2-fold rise	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	—	—	—
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 181/Day 1: >=4-fold rise	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	—	—	—
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 202/Day 1: >=2-fold rise	—	100 percentage of participants Interval 2.5 to 100.0	—	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 76.8 to 100.0
Percentage of Participants With >=2- and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 91, 112, 181, and 202 Day 202/Day 1: >=4-fold rise	—	100 percentage of participants Interval 2.5 to 100.0	—	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 76.8 to 100.0

SECONDARY outcome

Timeframe: Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)

GMTs of SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Titers were expressed in terms of 1/dilution. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=6 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=8 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=5 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=15 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=22 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 Day 91	—	—	13.7 titers Interval 6.7 to 28.1	113 titers Interval 10.2 to 1263.0	9.33 titers 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	—	—
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 Day 112	177 titers Interval 52.7 to 593.0	23.1 titers Interval 2.91 to 183.0	—	—	—	322 titers Interval 56.3 to 1842.0	69.5 titers Interval 31.4 to 154.0
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 Day 181	—	—	21.0 titers	2993 titers	—	—	—
Geometric Mean Titers of Neutralizing Antibody Titer Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 91, 112, 181, and 202 Day 202	—	3490 titers	—	—	—	45.0 titers	120 titers Interval 25.5 to 568.0

SECONDARY outcome

Timeframe: Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 91/Day 1, Day 181/Day 1; Cohort 2: Day 112/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=5 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=4 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=15 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=22 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 91/Day 1	—	—	3.17 ratio Interval 1.49 to 6.74	22.7 ratio Interval 2.03 to 253.0	2.18 ratio 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	—	—
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 112/Day 1	35.3 ratio Interval 10.5 to 119.0	2.76 ratio 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.	—	—	—	64.4 ratio Interval 11.3 to 368.0	13.9 ratio Interval 6.28 to 30.7
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 181/Day 1	—	—	4.20 ratio	599 ratio	—	—	—
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 202/Day 1	—	—	—	—	—	9.00 ratio	24.1 ratio Interval 5.09 to 114.0

SECONDARY outcome

Timeframe: Day 1 (pre-vaccination), Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)

SARS-CoV-2 neutralizing antibodies (D614G variant) was measured using a neutralization assay. Fold-rise (2-fold and 4-fold) was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 91/Day 1, Day 112/Day 1, Day 181/Day 1, and Day 202/Day 1. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=5 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=4 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=15 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=22 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 91/Day 1: >=2-fold rise	—	—	71.4 percentage of participants Interval 29.0 to 96.3	71.4 percentage of participants Interval 29.0 to 96.3	25.0 percentage of participants Interval 0.6 to 80.6	—	—
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 91/Day 1: >=4-fold rise	—	—	57.1 percentage of participants Interval 18.4 to 90.1	71.4 percentage of participants Interval 29.0 to 96.3	25.0 percentage of participants Interval 0.6 to 80.6	—	—
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 112/Day 1: >=2-fold rise	100 percentage of participants Interval 69.2 to 100.0	40.0 percentage of participants Interval 5.3 to 85.3	—	—	—	93.3 percentage of participants Interval 68.1 to 99.8	90.9 percentage of participants Interval 70.8 to 98.9
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 112/Day 1: >=4-fold rise	100 percentage of participants Interval 69.2 to 100.0	20.0 percentage of participants Interval 0.5 to 71.6	—	—	—	86.7 percentage of participants Interval 59.5 to 98.3	77.3 percentage of participants Interval 54.6 to 92.2
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 181/Day 1: >=2-fold rise	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	—	—	—
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 181/Day 1: >=4-fold rise	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	—	—	—
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 202/Day 1: >=2-fold rise	—	—	—	—	—	100 percentage of participants Interval 2.5 to 100.0	91.7 percentage of participants Interval 61.5 to 99.8
Percentage of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 91, 112, 181, and 202 Day 202/Day 1: >=4-fold rise	—	—	—	—	—	100 percentage of participants Interval 2.5 to 100.0	83.3 percentage of participants Interval 51.6 to 97.9

SECONDARY outcome

Timeframe: Cohort 1: Day 91, Day 181 and Cohort 2: Day 112, and Day 202 (post-vaccination)

Seroconversion was defined as participants with a Baseline (Day 1) titer values below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post injection. LLOQ of the neutralization assay was a titer of 10. Data for this OM was planned to be collected and analyzed for combined population (FEC + Sentinel Cohort) in which same dose-level groups in Sentinel Cohort and FEC were pooled for analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 Participants Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=5 Participants Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=7 Participants Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=4 Participants Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=15 Participants Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=22 Participants Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens Day 91	—	—	71.4 percentage of participants Interval 29.0 to 96.3	71.4 percentage of participants Interval 29.0 to 96.3	25.0 percentage of participants Interval 0.6 to 80.6	—	—
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens Day 112	100 percentage of participants Interval 69.2 to 100.0	40.0 percentage of participants Interval 5.3 to 85.3	—	—	—	93.3 percentage of participants Interval 68.1 to 99.8	90.9 percentage of participants Interval 70.8 to 98.9
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens Day 181	—	—	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	—	—	—
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens Day 202	—	—	—	—	—	100 percentage of participants Interval 2.5 to 100.0	91.7 percentage of participants Interval 61.5 to 99.8

SECONDARY outcome

Timeframe: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Population: Data was not collected and analyzed for this OM (virologically confirmed COVID-19 like illness) due to discontinuation of the development of the messenger ribonucleic acid (mRNA) COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.

Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Population: Data was not collected and analyzed for this OM (serologically confirmed SARS-CoV-2 infection) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.

Serologically-confirmed SARS-CoV-2 infection as defined by SARS-CoV-2 Nucleoprotein specific antibody detection immunoassay was reported in this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)

Population: Data was not collected and analyzed for this OM (Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2) due to discontinuation of the development of the mRNA COVID-19 vaccine by Sponsor. Hence, no further corresponding testing was conducted, and the planned efficacy analysis was not performed.

Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Cohort 1: SARS-CoV-2 Vaccine Low Dose

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Cohort 1: Placebo

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Cohort 2: SARS-CoV-2 Vaccine Low Dose

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Cohort 2: SARS-CoV-2 Vaccine Medium Dose

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Cohort 2: Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=37 participants at risk Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=34 participants at risk Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 participants at risk Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 participants at risk Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 participants at risk Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 participants at risk Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 participants at risk Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.
Infections and infestations Covid-19	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Renal and urinary disorders Cystitis Haemorrhagic	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.

Other adverse events

Other adverse events
Measure	Cohort 1: SARS-CoV-2 Vaccine Ultra Low Dose n=37 participants at risk Participants received a single IM injection of SARS-CoV-2 Vaccine ultra-low dose on Day 1.	Cohort 1: SARS-CoV-2 Vaccine Low Dose n=34 participants at risk Participants received a single IM injection of SARS-CoV-2 Vaccine low dose on Day 1.	Cohort 1: Placebo n=18 participants at risk Participants received a single IM injection of placebo matched to SARS-CoV-2 Vaccine on Day 1.	Cohort 2: SARS-CoV-2 Vaccine Ultra Low Dose n=36 participants at risk Participants received two IM injections of SARS-CoV-2 Vaccine ultra-low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Low Dose n=36 participants at risk Participants received two IM injections of SARS-CoV-2 Vaccine low dose on Day 1 and at Day 22, respectively.	Cohort 2: SARS-CoV-2 Vaccine Medium Dose n=10 participants at risk Participants received two IM injections of SARS-CoV-2 Vaccine medium dose on Day 1 and at Day 22, respectively.	Cohort 2: Placebo n=9 participants at risk Participants received two IM injections of placebo matched to SARS-CoV-2 Vaccine on Day 1 and at Day 22, respectively.
Eye disorders Eye Pain	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Gastrointestinal disorders Diarrhoea	2.7% 1/37 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.9% 2/34 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	20.0% 2/10 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 1/9 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Gastrointestinal disorders Dyspepsia	2.7% 1/37 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Gastrointestinal disorders Flatulence	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Gastrointestinal disorders Nausea	2.7% 1/37 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.9% 1/34 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 2/36 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Gastrointestinal disorders Vomiting	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 2/36 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Axillary Pain	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Chills	37.8% 14/37 • Number of events 14 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	50.0% 17/34 • Number of events 17 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	22.2% 4/18 • Number of events 4 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	55.6% 20/36 • Number of events 32 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	80.6% 29/36 • Number of events 48 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	90.0% 9/10 • Number of events 15 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 1/9 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Injection Site Erythema	5.4% 2/37 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 4/36 • Number of events 5 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	13.9% 5/36 • Number of events 9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Injection Site Pain	75.7% 28/37 • Number of events 28 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	82.4% 28/34 • Number of events 28 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	27.8% 5/18 • Number of events 5 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	91.7% 33/36 • Number of events 57 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	91.7% 33/36 • Number of events 64 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	100.0% 10/10 • Number of events 20 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	22.2% 2/9 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Injection Site Swelling	2.7% 1/37 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.9% 2/34 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	16.7% 6/36 • Number of events 7 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 4/36 • Number of events 5 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	20.0% 2/10 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Malaise	56.8% 21/37 • Number of events 21 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	61.8% 21/34 • Number of events 21 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	27.8% 5/18 • Number of events 5 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	77.8% 28/36 • Number of events 47 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	86.1% 31/36 • Number of events 56 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	100.0% 10/10 • Number of events 18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	22.2% 2/9 • Number of events 4 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
General disorders Pyrexia	13.5% 5/37 • Number of events 5 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	23.5% 8/34 • Number of events 8 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	27.8% 10/36 • Number of events 14 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	44.4% 16/36 • Number of events 23 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	100.0% 10/10 • Number of events 18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Infections and infestations Covid-19	8.1% 3/37 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	8.8% 3/34 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	8.3% 3/36 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 1/9 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Infections and infestations Tooth Infection	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Nervous system disorders Headache	48.6% 18/37 • Number of events 18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	52.9% 18/34 • Number of events 18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	38.9% 7/18 • Number of events 8 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	72.2% 26/36 • Number of events 44 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	86.1% 31/36 • Number of events 55 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	100.0% 10/10 • Number of events 16 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	55.6% 5/9 • Number of events 6 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Investigations Sars-Cov-2 Test Positive	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Musculoskeletal and connective tissue disorders Arthralgia	18.9% 7/37 • Number of events 7 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	38.2% 13/34 • Number of events 13 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 2/18 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	55.6% 20/36 • Number of events 28 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	63.9% 23/36 • Number of events 37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	100.0% 10/10 • Number of events 12 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	22.2% 2/9 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Musculoskeletal and connective tissue disorders Back Pain	2.7% 1/37 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Musculoskeletal and connective tissue disorders Muscle Tightness	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Musculoskeletal and connective tissue disorders Myalgia	54.1% 20/37 • Number of events 20 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	67.6% 23/34 • Number of events 23 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	22.2% 4/18 • Number of events 4 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	77.8% 28/36 • Number of events 45 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	77.8% 28/36 • Number of events 49 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	80.0% 8/10 • Number of events 15 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	22.2% 2/9 • Number of events 4 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Nervous system disorders Dizziness	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 2/18 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 2/36 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Nervous system disorders Hypoaesthesia	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Nervous system disorders Paraesthesia	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Psychiatric disorders Anxiety	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 1/9 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Psychiatric disorders Depression	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 1/9 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Respiratory, thoracic and mediastinal disorders Cough	8.1% 3/37 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	5.4% 2/37 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 2/36 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	10.0% 1/10 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	8.1% 3/37 • Number of events 3 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	2.8% 1/36 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	11.1% 1/9 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 1/18 • Number of events 1 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 2/36 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.
Respiratory, thoracic and mediastinal disorders Sinus Pain	0.00% 0/37 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/34 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/18 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	5.6% 2/36 • Number of events 2 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/36 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/10 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.	0.00% 0/9 • Unsolicited AEs were collected within 21 days post-vaccination. Solicited reaction data were collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 groups and up to Day 387 for Cohort 2 groups) SafAS population. In AE section, SR, Fever was reported as Pyrexia. AEs were planned to be collected \& analyzed for combined population in which the same dose-level groups in Sentinel \& FEC were pooled for analysis. One participant of Sentinel Cohort (ultra-low dose) who was supposed to receive 2 doses received only 1 ultra-low dose and thus was counted into Cohort 1: ultra-low dose (N = 37; 1 from sentinel cohort and 36 from FEC cohort 1) based on actual injection scheme.

Additional Information

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