Trial Outcomes & Findings for Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children (NCT NCT05634811)

Last Updated: 2026-05-07

Results Overview

Local reactions included pain at injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3547 participants

Primary outcome timeframe

From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)

Results posted on

2026-05-07

Participant Flow

A total of 3646 participants were enrolled, of which 3547 participants were randomized.

This study was conducted across 57 sites across the United States of America (USA).

Participant milestones

Participant milestones
Measure	VLA15: 5 to 11 Years Participants aged 5 to 11 years were randomized to receive Lyme borreliosis 6-valent vaccine (VLA15 \[PF-07307405\]), 180 micrograms (ug), 0.5 milliliter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 5 to 11 Years Participants aged 5 to 11 years were randomized to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years Participants aged 12 to 17 years were randomized to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years Participants aged 12 to17 years were randomized to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Overall Study COMPLETED	1209	389	997	350
Overall Study NOT COMPLETED	223	86	224	69
Overall Study STARTED	1432	475	1221	419
Overall Study Vaccinated	1429	467	1219	418

Reasons for withdrawal

Reasons for withdrawal
Measure	VLA15: 5 to 11 Years Participants aged 5 to 11 years were randomized to receive Lyme borreliosis 6-valent vaccine (VLA15 \[PF-07307405\]), 180 micrograms (ug), 0.5 milliliter (mL) intramuscular (IM) injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 5 to 11 Years Participants aged 5 to 11 years were randomized to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years Participants aged 12 to 17 years were randomized to receive VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years Participants aged 12 to17 years were randomized to receive placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Overall Study Physician Decision	9	3	5	2
Overall Study Withdrawal by Subject	45	12	49	16
Overall Study No longer met eligibility criteria	3	0	7	1
Overall Study Withdrawal by parent or guardian	50	18	42	11
Overall Study Lost to Follow-up	96	43	106	34
Overall Study Medication error without associated adverse event	2	0	0	0
Overall Study Other	5	1	3	0
Overall Study Randomized but not treated	3	8	2	1
Overall Study Adverse Event	10	1	10	4

Baseline Characteristics

Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VLA15: 5 to 11 Years n=1429 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 5 to 11 Years n=467 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	Total n=3533 Participants Total of all reporting groups
Age, Continuous	8.2 Years STANDARD_DEVIATION 2.0 • n=54 Participants	8.2 Years STANDARD_DEVIATION 2.0 • n=60 Participants	14.3 Years STANDARD_DEVIATION 1.7 • n=114 Participants	14.3 Years STANDARD_DEVIATION 1.7 • n=318 Participants	11 Years STANDARD_DEVIATION 3.5 • n=280 Participants
Sex: Female, Male Female	653 Participants n=54 Participants	214 Participants n=60 Participants	596 Participants n=114 Participants	182 Participants n=318 Participants	1645 Participants n=280 Participants
Sex: Female, Male Male	776 Participants n=54 Participants	253 Participants n=60 Participants	623 Participants n=114 Participants	236 Participants n=318 Participants	1888 Participants n=280 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	240 Participants n=54 Participants	75 Participants n=60 Participants	268 Participants n=114 Participants	90 Participants n=318 Participants	673 Participants n=280 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1181 Participants n=54 Participants	391 Participants n=60 Participants	944 Participants n=114 Participants	327 Participants n=318 Participants	2843 Participants n=280 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=54 Participants	1 Participants n=60 Participants	7 Participants n=114 Participants	1 Participants n=318 Participants	17 Participants n=280 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=54 Participants	2 Participants n=60 Participants	5 Participants n=114 Participants	0 Participants n=318 Participants	9 Participants n=280 Participants
Race (NIH/OMB) Asian	32 Participants n=54 Participants	12 Participants n=60 Participants	27 Participants n=114 Participants	12 Participants n=318 Participants	83 Participants n=280 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=54 Participants	0 Participants n=60 Participants	2 Participants n=114 Participants	0 Participants n=318 Participants	4 Participants n=280 Participants
Race (NIH/OMB) Black or African American	262 Participants n=54 Participants	99 Participants n=60 Participants	208 Participants n=114 Participants	72 Participants n=318 Participants	641 Participants n=280 Participants
Race (NIH/OMB) White	1081 Participants n=54 Participants	342 Participants n=60 Participants	947 Participants n=114 Participants	320 Participants n=318 Participants	2690 Participants n=280 Participants
Race (NIH/OMB) More than one race	37 Participants n=54 Participants	8 Participants n=60 Participants	20 Participants n=114 Participants	9 Participants n=318 Participants	74 Participants n=280 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=54 Participants	4 Participants n=60 Participants	10 Participants n=114 Participants	5 Participants n=318 Participants	32 Participants n=280 Participants

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)

Population: Safety population included all enrolled participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=457 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1206 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=410 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1408 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 1	34.8 Percentage of participants Interval 30.4 to 39.4	80.6 Percentage of participants Interval 78.3 to 82.8	14.6 Percentage of participants Interval 11.4 to 18.4	80.8 Percentage of participants Interval 78.6 to 82.8

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)

Local reactions included pain at injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 local reaction of any grade were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=431 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1112 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=386 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1297 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 2	29.0 Percentage of participants Interval 24.8 to 33.5	71.4 Percentage of participants Interval 68.6 to 74.0	11.7 Percentage of participants Interval 8.6 to 15.3	72.6 Percentage of participants Interval 70.0 to 75.0

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=391 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1054 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=372 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1225 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 3	25.1 Percentage of participants Interval 20.8 to 29.7	69.6 Percentage of participants Interval 66.8 to 72.4	9.7 Percentage of participants Interval 6.9 to 13.1	73.5 Percentage of participants Interval 70.9 to 75.9

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=384 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=979 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=349 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1169 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)	24.7 Percentage of participants Interval 20.5 to 29.4	71.6 Percentage of participants Interval 68.7 to 74.4	11.7 Percentage of participants Interval 8.6 to 15.6	77.0 Percentage of participants Interval 74.5 to 79.4

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after any study vaccination

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=466 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1212 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=415 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1428 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Local Reaction of Any Grade for up to 7 Days After Any Study Vaccination	56.0 Percentage of participants Interval 51.4 to 60.6	90.0 Percentage of participants Interval 88.2 to 91.6	31.6 Percentage of participants Interval 27.1 to 36.3	88.3 Percentage of participants Interval 86.5 to 89.9

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 1 (Vaccination on Day 1, Month 0)

Systemic events included fever, fatigue, headache, muscle pain and joint pain and were recorded by participants in the e-diary or by investigators in CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol based on CBER toxicity guidelines. Percentage of participants with at least 1 systemic event of any grade were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=456 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1205 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=410 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1406 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 1	41.0 Percentage of participants Interval 36.5 to 45.7	62.2 Percentage of participants Interval 59.4 to 64.9	48.8 Percentage of participants Interval 43.8 to 53.7	56.0 Percentage of participants Interval 53.3 to 58.6

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 2 (Vaccination on Day 1, Month 2)

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=430 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1111 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=386 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1296 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 2	30.2 Percentage of participants Interval 25.9 to 34.8	55.3 Percentage of participants Interval 52.3 to 58.2	31.6 Percentage of participants Interval 27.0 to 36.5	48.1 Percentage of participants Interval 45.3 to 50.8

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 3 (Vaccination on Day 1, Month 6)

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=391 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1055 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=371 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1224 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 3	27.6 Percentage of participants Interval 23.2 to 32.3	51.6 Percentage of participants Interval 48.5 to 54.6	26.1 Percentage of participants Interval 21.7 to 30.9	47.5 Percentage of participants Interval 44.6 to 50.3

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after Study Vaccination 4 (Vaccination on Day 1, Month 18)

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=384 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=977 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=349 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1169 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days Following Study Vaccination 4 (Booster Dose)	28.1 Percentage of participants Interval 23.7 to 32.9	54.8 Percentage of participants Interval 51.6 to 57.9	28.4 Percentage of participants Interval 23.7 to 33.4	53.5 Percentage of participants Interval 50.6 to 56.4

PRIMARY outcome

Timeframe: From Day 1 through Day 7 after any study vaccination

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=466 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1212 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=415 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1427 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With at Least 1 Systemic Event of Any Grade for up to 7 Days After Any Study Vaccination	60.1 Percentage of participants Interval 55.5 to 64.6	82.1 Percentage of participants Interval 79.8 to 84.2	63.1 Percentage of participants Interval 58.3 to 67.8	77.8 Percentage of participants Interval 75.5 to 79.9

PRIMARY outcome

Timeframe: From Day 1 through 1 Month after Study Vaccination 1 (Vaccination on Day 1, Month 0)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 1 were included in this outcome measure. AEs included both serious AEs (SAEs) and non-SAEs.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=467 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1426 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 1	3.0 Percentage of participants Interval 1.6 to 5.0	3.1 Percentage of participants Interval 2.2 to 4.3	4.5 Percentage of participants Interval 2.8 to 7.0	3.4 Percentage of participants Interval 2.6 to 4.5

PRIMARY outcome

Timeframe: From Day 1 through 1 Month after Study Vaccination 2 (Vaccination on Day 1, Month 2)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 2 were included in this outcome measure. AEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=452 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1173 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=406 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1371 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 2	2.2 Percentage of participants Interval 1.1 to 4.0	1.5 Percentage of participants Interval 0.9 to 2.4	2.2 Percentage of participants Interval 1.0 to 4.2	2.4 Percentage of participants Interval 1.7 to 3.4

PRIMARY outcome

Timeframe: From Day 1 through 1 Month after Study Vaccination 3 (Vaccination on Day 1, Month 6)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 3 were included in this outcome measure. AEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=428 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1126 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=397 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1313 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 3	3.5 Percentage of participants Interval 2.0 to 5.7	4.6 Percentage of participants Interval 3.5 to 6.0	4.3 Percentage of participants Interval 2.5 to 6.8	4.6 Percentage of participants Interval 3.5 to 5.8

PRIMARY outcome

Timeframe: From Day 1 through 1 Month after Study Vaccination 4 (Vaccination on Day 1, Month 18)

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) after dose 4 were included in this outcome measure. AEs included both SAEs and non-SAEs.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=396 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1019 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=360 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1226 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With AEs Through 1 Month Following Study Vaccination 4 (Booster Dose)	2.5 Percentage of participants Interval 1.2 to 4.6	4.1 Percentage of participants Interval 3.0 to 5.5	4.7 Percentage of participants Interval 2.8 to 7.5	4.1 Percentage of participants Interval 3.0 to 5.3

PRIMARY outcome

Timeframe: From Day 1 through 1 Month after any study vaccination

Population: Safety population included all enrolled participants who received at least 1 dose of the study intervention.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=467 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1429 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With AEs Through 1 Month Following Any Study Vaccination	8.6 Percentage of participants Interval 6.2 to 11.5	11.2 Percentage of participants Interval 9.5 to 13.1	12.2 Percentage of participants Interval 9.2 to 15.7	11.7 Percentage of participants Interval 10.1 to 13.5

PRIMARY outcome

Timeframe: Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)

Population: Safety population included all enrolled participants who received at least 1 dose of the study intervention.

An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. NDCMCs included conditions that were undiagnosed prior to study entry (diagnosed while in the study and confirmed not to be a preexisting condition) and that were not considered temporary conditions based upon the expected natural history of the condition. An NDCMC was not reported on AE CRF.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=467 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1429 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study	1.9 Percentage of participants Interval 0.9 to 3.6	2.1 Percentage of participants Interval 1.4 to 3.1	3.3 Percentage of participants Interval 1.8 to 5.6	2.7 Percentage of participants Interval 1.9 to 3.7

PRIMARY outcome

Timeframe: Throughout the study (from study vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months)

Population: Safety population included all enrolled participants who received at least 1 dose of the study intervention.

An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other important medical event.

Outcome measures

Outcome measures
Measure	Placebo: 5 to 11 Years n=467 Participants Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 Participants Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 Participants Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 5 to 11 Years n=1429 Participants Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.
Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study	0.9 Percentage of participants Interval 0.2 to 2.2	2.2 Percentage of participants Interval 1.5 to 3.2	2.4 Percentage of participants Interval 1.2 to 4.4	1.0 Percentage of participants Interval 0.6 to 1.7

Adverse Events

VLA15: 5 to 11 Years

Serious events: 15 serious events

Other events: 1290 other events

Deaths: 0 deaths

Placebo: 5 to 11 Years

Serious events: 4 serious events

Other events: 341 other events

Deaths: 0 deaths

VLA15: 12 to 17 Years

Serious events: 27 serious events

Other events: 1121 other events

Deaths: 0 deaths

Placebo: 12 to 17 Years

Serious events: 10 serious events

Other events: 295 other events

Deaths: 1 deaths

VLA15: Overall

Serious events: 42 serious events

Other events: 2411 other events

Deaths: 0 deaths

Placebo: Overall

Serious events: 14 serious events

Other events: 636 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	VLA15: 5 to 11 Years n=1429 participants at risk Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 5 to 11 Years n=467 participants at risk Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 participants at risk Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 participants at risk Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: Overall n=2648 participants at risk Participants aged 5 to 17 years received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: Overall n=885 participants at risk Participants aged 5 to 17 years received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
Congenital, familial and genetic disorders Arnold-Chiari malformation	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Gastrointestinal disorders Anal fistula	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Gastrointestinal disorders Constipation	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Gastrointestinal disorders Crohn's disease	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Gastrointestinal disorders Nausea	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Appendicitis	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.21% 1/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.16% 2/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 3/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Appendicitis perforated	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.16% 2/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 2/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Cellulitis orbital	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Immune system disorders Food allergy	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Influenza myocarditis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Mastoiditis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Mycoplasma infection	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Osteomyelitis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Periorbital abscess	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.21% 1/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Periorbital cellulitis	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Pharyngitis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Pneumonia	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 2/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Pyelonephritis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Respiratory tract infection viral	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Subperiosteal abscess	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Tonsillitis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Injury, poisoning and procedural complications Thermal burn	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Injury, poisoning and procedural complications Vulvovaginal injury	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.48% 2/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.23% 2/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.14% 2/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 2/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Musculoskeletal and connective tissue disorders Chronic recurrent multifocal osteomyelitis	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease nodular sclerosis stage IV	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Nervous system disorders Central nervous system lesion	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Nervous system disorders Epilepsy	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Nervous system disorders Tethered cord syndrome	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Depression	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.16% 2/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 3/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Disruptive mood dysregulation disorder	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Drug abuse	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Oppositional defiant disorder	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Suicidal ideation	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.21% 1/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.25% 3/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 3/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Suicide attempt	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.16% 2/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 2/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.21% 1/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.07% 1/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.24% 1/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.11% 1/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Substance-induced psychotic disorder	0.00% 0/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.08% 1/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.04% 1/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.

Other adverse events

Other adverse events
Measure	VLA15: 5 to 11 Years n=1429 participants at risk Participants aged 5 to 11 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 5 to 11 Years n=467 participants at risk Participants aged 5 to 11 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: 12 to 17 Years n=1219 participants at risk Participants aged 12 to 17 years who received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: 12 to 17 Years n=418 participants at risk Participants aged 12 to17 years who received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.	VLA15: Overall n=2648 participants at risk Participants aged 5 to 17 years received VLA15, 180 ug, 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a booster dose of VLA15 at Month 18.	Placebo: Overall n=885 participants at risk Participants aged 5 to 17 years received placebo (normal saline) 0.5 mL IM injection at Month 0, 2 and 6. Eligible participants received a placebo IM injection at Month 18.
General disorders Fatigue (FATIGUE)	61.2% 875/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	46.9% 219/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	63.1% 769/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	46.2% 193/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	62.1% 1644/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	46.6% 412/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
General disorders Injection site erythema	1.4% 20/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.98% 12/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.2% 32/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
General disorders Injection site pain	2.8% 40/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.86% 4/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.4% 29/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.96% 4/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.6% 69/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.90% 8/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
General disorders Injection site pain (PAIN AT INJECTION SITE)	87.1% 1245/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	53.5% 250/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	88.9% 1084/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	31.1% 130/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	88.0% 2329/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	42.9% 380/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
General disorders Injection site swelling	1.4% 20/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.57% 7/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.0% 27/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.00% 0/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
General disorders Pyrexia (FEVER)	13.5% 193/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	6.2% 29/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	7.3% 89/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	4.5% 19/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	10.6% 282/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	5.4% 48/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
General disorders Swelling (SWELLING)	52.6% 752/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	9.6% 45/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	22.7% 277/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.7% 7/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	38.9% 1029/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	5.9% 52/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations COVID-19	1.3% 18/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.43% 2/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.82% 10/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.2% 9/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.1% 28/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.2% 11/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Influenza	0.84% 12/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.3% 6/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.41% 5/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.96% 4/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.64% 17/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.1% 10/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Pharyngitis streptococcal	3.3% 47/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	3.0% 14/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.98% 12/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.2% 5/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.2% 59/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.1% 19/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Infections and infestations Upper respiratory tract infection	2.2% 31/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.8% 13/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.0% 24/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	3.8% 16/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.1% 55/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	3.3% 29/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Injury, poisoning and procedural complications Fall	0.14% 2/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.1% 5/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.41% 5/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.72% 3/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.26% 7/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.90% 8/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Musculoskeletal and connective tissue disorders Arthralgia (JOINT PAIN)	26.2% 375/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	13.7% 64/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	29.0% 353/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	15.6% 65/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	27.5% 728/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	14.6% 129/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Musculoskeletal and connective tissue disorders Myalgia (MUSCLE PAIN)	50.2% 717/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	24.0% 112/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	52.3% 637/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	26.3% 110/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	51.1% 1354/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	25.1% 222/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Nervous system disorders Headache (HEADACHE)	52.5% 750/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	41.1% 192/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	60.2% 734/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	43.1% 180/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	56.0% 1484/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	42.0% 372/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Attention deficit hyperactivity disorder	1.9% 27/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.7% 8/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.57% 7/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.2% 5/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.3% 34/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.5% 13/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Psychiatric disorders Depression	0.14% 2/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.21% 1/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.74% 9/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	1.7% 7/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.42% 11/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	0.90% 8/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.
Skin and subcutaneous tissue disorders Erythema (REDNESS)	62.4% 891/1429 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	16.3% 76/467 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	25.0% 305/1219 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	2.9% 12/418 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	45.2% 1196/2648 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.	9.9% 88/885 • Local reactions and systemic events: Day 1 to Day 7 after each study vaccination; SAEs, All-cause mortality: Throughout the study (from study Vaccination 1 through 6 months post study Vaccination 4 [Booster dose]: maximum up to 24 months); Other AEs: From Day 1 through 1 Month after any study vaccination Same events may appear as both other AE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all enrolled participants who received at least 1 dose of the study intervention.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER